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ASBESTOS NEWS DAILY - MESOTHELIOMA CLINICAL TRIALS
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Mesothelioma Clinical Trials


 
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Clinical Trials – Asbestos Treatment – Mesothelioma Clinical Trials

 

More Than Thirty Mesothelioma Clinical Trials Are Underway

Posted on Tuesday, May 04, 2010.

 

mesothelioma clinical trialClinical trials are human studies of new drugs and treatments to determine whether or not they should be approved by the FDA. Clinical trials formesothelioma are ongoing, primarily at major medical centers around the country.  Becausemesothelioma is an aggressive cancer, many trials are focused on ways to detect it earlier and treat it more effectively with various combinations of therapies. 

Although participation in amesothelioma trial may sound like a good way to connect with promising new treatments, not everymesothelioma patient is a candidate.  Because clinical trials are established with specific goals, most have very specific guidelines as to the type of patients they are willing to treat.  For example, some trials only accept patients who have received little or no benefit from other therapies, while others only take people who have not yet started any treatment. 

Mesothelioma trials like all clinical trials are conducted in three phases.  Phase I trials generally recruit a smaller number of participants and focus on determining safety and dosing.  In Phase II trials, researchers try to determine if a drug or treatment actually has efficacy.  If the treatment shows promise and is safe, its effectiveness is compared to that of existing treatments in a Phase III trial. 

There are both advantages and disadvantages to being involved in amesothelioma clinical trial.  Even if a patient meets the criteria for a trial and is accepted to participate, there is no guarantee that they will receive the new treatment, since some trials require a group of participants to receive the old treatments for a basis of comparison.  In addition, the time spent ‘experimenting’ in a clinical trial could be used instead to be receiving a proven existing treatment.

On the positive side, clinical trial participants often receive excellent health care since they must be monitored closely as part of the study.  There is the possibility that a new treatment may offer real benefits over existing treatments.  And there is the intangible benefit of at least increasing a knowledge base that may lead to better treatments in the future.

Although chemotherapy, radiation and surgery remain the primary treatments againmesothelioma, many of the newest trials are focused on therapies that are able to target the tumor cells more effectively, without harming surrounding tissues. Some of these newer drugs aim to slow tumor growth by robbing cells of vital enzymes, inhibiting their ability to replicate, or harnessing the body’s own immune system to attack them. 

The National Institute of Health provides a current list of ongoingclinical trials formesothelioma.  Some of the studies going on now include:

• Studies of several new oral medications against advanced pleuralmesothelioma where traditional chemotherapy has failed

• A study of an under-the-tongue spray medication formesothelioma pain

• Several studies on the addition of a third chemotherapy drug to the standard two-drug mixture

• A study on the effectiveness of video-assisted surgery formesothelioma tumors

• A study on the effectiveness of administering a heated chemotherapy drug in the operating room, immediately followingmesothelioma surgery

• A study on a new drug,AZD2171, that may stop the growth of tumors in patients who are not candidates for surgery

• A study on the effectiveness of combining chemotherapy with Intensity Modulated Radiation Therapy inmesothelioma

• Gene therapy for pleuralmesothelioma

More than 30 clinical trials formesothelioma are currently underway in theU.S. For a complete list of studies that are recruiting, locations and participation requirements, visit the National Cancer Institute.

Source:

National Cancer Institute, Clinical Trial Information.Accessed April 30, 2010.

 

©Surviving Mesothelioma and Cancer Monthly.  All rights reserved.

 

http://www.survivingmesothelioma.com/news/view.asp?ID=00433

 
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Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation Therapy forMesothelioma

This study is currently recruiting participants.

Verified by University Health Network,Toronto, May 2009

First Received: May 6, 2009   Last Updated: May 7, 2009   History of Changes

Sponsor:

University Health Network,Toronto

Collaborator:

Eli Lilly and Company

Information provided by:

University Health Network,Toronto

ClinicalTrials.gov Identifier:

NCT00895648

  Purpose

Despite the best surgical efforts, complete removal ofmesothelioma is possible in approximately 30% of the patients. When surgical removal is complete, chemotherapy followed by radiation therapy is recommended as an effort to improve control over the cancer and survival. This combination of treatments is called TRIMODALITY therapy. Unfortunately, the chances for the tumor coming back after TRIMODALITY therapy remains high. When surgical removal is not complete or not possible, some patients may receive chemo and/or radiation therapy to achieve control over the cancer, but the chances of tumor to growth again remains high and the chances of long term survival remains low.

The combination of Pemetrexed (Alimta) with Cisplatin has been approved as one of the standard chemotherapy drug combinations for the treatment in advanced Malignant PleuralMesothelioma, and there is likely a group of patients who may benefit and potentially be cured by this therapy. In an effort to achieve a better chance of complete removal of the cancer and long term survival, the investigators are interested in using this drug combination of Pemetrexed + Cisplatin before surgery and offer radiation therapy after surgery.



Condition

Intervention

Phase

Mesothelioma
PleuralMesothelioma

Drug: Pemetrexed
Drug: Cisplatin

Phase II

 

Study Type:

Interventional

Study Design:

Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:

Phase II Study of Neo-Adjuvant Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation Therapy for Malignant PleuralMesothelioma

 

Resource links provided by NLM:

 

MedlinePlus related topics:CancerMesotheliomaSurgery

Drug Information available for:CisplatinPemetrexedPemetrexed disodium

U.S. FDA Resources

 

Further study details as provided by University Health Network,Toronto:

 

Primary Outcome Measures:

  • median relapse-free survival (RFS) [ Time Frame: 15 months ] [ Designated as safety issue: No ]

 

Estimated Enrollment:

45

Study Start Date:

January 2009

Estimated Study Completion Date:

January 2020

Estimated Primary Completion Date:

January 2020 (Final data collection date for primary outcome measure)

Intervention Details:

Drug: Pemetrexed

500 mg/m² iv infusion every 3 weeks for 3 cycles

Drug: Cisplatin

75 mg/m² iv infusion every 3 weeks for 3 cycles

  Eligibility

Ages Eligible for Study:  

18 Years and older

Genders Eligible for Study:  

Both

Accepts Healthy Volunteers:  

No

Criteria

Inclusion Criteria:

1.     Histologically proven diagnosis of MPM stages I to III. Patients will be clinically staged using the AJCC/UICC TNM staging criteria (see Protocol Appendix 2). Eligible stages:

    • Patients must be M0.
    • Patients with T1, T2, and T3 disease (without cardiac involvement) are eligible. T status can be established clinically and radiologically or at exploratory thoracotomy without surgical resection.
    • Patients with N0, N1, or N2 disease are eligible.
  1. Performance status of 0 to 2 on the ECOG performance status schedule. See protocol Appendix 3
  2. No prior systemic chemotherapy. No prior intracavitary cytotoxic drugs or immunomodulators, unless given for the purpose of chemical pleurodesis.
  3. No previous surgical procedure for mesothelioma, with the exception of previous chemical pleurodesis and biopsy.
  4. No previous radiation therapy for mesothelioma, or to the thorax.
  5. Patients must be judged to be suitable candidates for this therapy at the UHN by the attending medical oncologist, thoracic surgeon, and radiation oncologist before enrolment.
  6. Estimated life expectancy of at least 12 weeks.

8.     Adequate organ function including the following:

    • Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ³1,500/uL , platelets ³100,000/uL, hemoglobin ³ 9g/dL
    • Hepatic: bilirubin £1.5 times institutional upper limit of normal, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) £3 times institutional upper limit of normal
    • Renal: Creatinine £1.5 times institutional upper limit of normal; or Creatinine clearance ³50 mL/min/1.73 m² for patients with creatinine levels above institutional normal upper limit level. Cockcrot and Gault formula Appendix 4.
    • Pulmonary function tests:

Predicted post-operative DLCO (ppoDLCO) of > 35%.

If the ppoDLCO is </= 35%, then additional studies will be done to determine the patient's ability to tolerate the resection. The surgeon will correlate these results with the patient's clinical status and make a decision as to the feasibility of resection.

  1. Female patients of childbearing potential must test negative for pregnancy at the time of enrolment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of radiation therapy.
  2. Patients must sign an informed consent

Exclusion Criteria:

  1. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  2. Have previously completed or withdrawn from this study or any other study investigating pemetrexed
  3. Pregnancy or breast-feeding.
  4. Serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
  5. Second active primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanomatous carcinoma of the skin, low grade (Gleason score < 6) localized adenocarcinoma of the prostate or other malignancy treated at least 2 years previously with no evidence of recurrence.
  6. Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8 day period for long-acting agents such as piroxicam).
  7. Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
  8. Refusal to have any of the treatment in the protocol (chemotherapy, extrapleural pneumonectomy, and radiation therapy).

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895648


Contacts

Contact: Andrea Foster

416-946-4501 ext 5010

Andrea.Foster@Uhn.on.ca

Contact: Jennifer Hornby, BSc CCRP

416-340-4857

Jennifer.Hornby@uhn.on.ca



Locations

Canada,Ontario

University Health Network

Recruiting

Toronto,Ontario,Canada, M5G 2M9

Contact: Andrea Foster     416-946-4501 ext 5010     Andrea.Foster@uhn.on.ca    

Contact: Jennifer Hornby, BSc CCRP     416-340-4857     Jennifer.Hornby@uhn.on.ca    

Principal Investigator: Ron Feld, MD            

Sub-Investigator: Marc dePerrot, MD            

Sub-Investigator: John Cho, MD            

Sponsors and Collaborators

University Health Network,Toronto

Eli Lilly and Company

Investigators

Principal Investigator:

Ron Feld, MD

University Health Network,Toronto

  More Information


No publications provided

Responsible Party:

University Health Network ( Dr. Ron Feld )

Study ID Numbers:

05-0815-C

Study First Received:

May 6, 2009

Last Updated:

May 7, 2009

ClinicalTrials.gov Identifier:

NCT00895648     History of Changes

Health Authority:

Canada: HealthCanada


Keywords provided by University Health Network,Toronto:

Meso
mesothelioma
pleura
pleural


Additional relevant MeSH terms:

Mesothelioma
Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Folic Acid Antagonists
Pharmacologic Actions
Pemetrexed
Neoplasms
Cisplatin
Radiation-Sensitizing Agents
Therapeutic Uses
Adenoma
Neoplasms, Glandular and Epithelial


ClinicalTrials.gov processed this record on December 17, 2009

http://clinicaltrials.gov/ct2/show/NCT00895648?term=mesothelioma&rank=2

 
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Bionomics to conduct trials on anti-cancer drug

ELI GREENBLAT

December 9, 2009 - 11:53AM

Junior biotechnology company Bionomics will conduct a Phase II clinical trial of its BNC105 anti-cancer drug on 60 mesothelioma patients at up to 12 centres acrossAustralia.

The company said this morning it had contracted the Australasian Lung Cancer Trials Group (ALTG) and the NHMRC Clinical Trials Centre (CTC) to conduct the clinical trial.

The drug trial will be the second planned Phase II clinical trial of the anti-cancer properties of BNC105 after Bionomics announced a US-based Phase II renal cancer trial earlier this year.

BNC105 is a novel anti-cancer agent which is both a vascular disrupting agent (VDA) and an inhibitor of cancer cell proliferation.

The new trial follows a successful BNC105 Phase I clinical trial in patients with advanced cancers at the Peter MacCallum Cancer Centre, theWesternHospital, Austin Health and theRoyalMelbourneHospital.

Mesothelioma is a form of cancer mostly associated with asbestos. The disease allows malignant cells to develop in the protective lining that covers most of the body's internal organs. Its most common site is the outer lining of the lungs and internal chest wall.

http://www.smh.com.au/business/bionomics-to-conduct-trials-on-anticancer-drug-20091209-kis1.html

 
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Rosetta Genomics Names Genetic Technologies Limited Exclusive Distributor for Rosetta's microRNA-based Assays inAustralia,New Zealand andSingapore

·        GTG Will Distribute Rosetta Genomics’ Three Recently Launched miRview™ Tests in Australia,New Zealand andSingapore

·        By Leveraging Unique Biomarkers Called microRNAs, Rosetta’s miRview™ Tests Can Offer Patients and Physicians New Insights on Cancer

  • Press Release
  • Source: Rosetta Genomics, Ltd.
  • On 7:30 am EDT, Thursday October 22, 2009

REHOVOT, Israel & PHILADELPHIA & MELBOURNE, Australia--(BUSINESS WIRE)--Rosetta Genomics, Ltd. (NASDAQ:ROSG - News), a leading developer of microRNA-based molecular diagnostics, and Genetic Technologies Limited (GTG) (NASDAQ:GENE - News) (ASX:GTG - News), the leading private genetic testing laboratory in Australia, announced today the signing of an exclusive distribution agreement for Rosetta Genomics’ three currently available diagnostic tests. Under the terms of the agreement, GTG will market Rosetta Genomics’ miRview™ tests inAustralia,New Zealand andSingapore. Further financial terms were not disclosed.

 “We have made remarkable progress in making our tests so widely available in the short time since they were launched early this year,” said Ronen Tamir, Chief Commercialization Officer of Rosetta Genomics. “We note that this distribution agreement marks Rosetta Genomics’ first entry into thePacific Rim and represents the fifth continent on which our miRview™ tests will be sold.”

Mr. Tamir added, “Genetic Technologies is the leading marketer of genetic tests for a host of indications, including breast cancer, inOceania. In addition, distinguishing mesothelioma from other lung cancers may be a particularly important task inAustralia, where the mining industry is a key component of the country’s economy. We are very excited to be working with GTG to improve patient care.”

Paul MacLeman, Chief Executive Officer of Genetic Technologies, said, “This is an important first step in Genetic Technologies’ move from predictive gene tests into advanced cancer management. We are seeking to leverage in-house developed tests through partnering with third party developers of novel tests. Through this approach, the company is aiming to rapidly build a comprehensive portfolio of genetic tools enabling oncologists to more effectively manage patient diagnosis and therapy, which may improve treatment outcomes. Genetic Technologies is very excited to announce its relationship with Rosetta Genomics, an acknowledged leader in the area of microRNA diagnostic test development.”

The following tests will be distributed by Genetic Technologies:

  • miRview™ mets – This test can accurately identify the primary tumor site in patients presenting with metastatic cancer, as well in patients whose tumor has not been identified, and consequently been labeled Cancer of Unknown Primary (CUP). As metastases need to be treated according to their primary origin, accurate identification of the metastases’ primary origin can be critical for determining appropriate treatment. Current diagnostic methods to identify the origin of a metastasis include a wide range of costly, time consuming and at times inefficient tests.miRview™ mets offers physicians a fast, accurate and easy-to-interpret diagnosis of the predicted primary origin.
  • miRview™ squamous – Using a single microRNA, miRview™ squamous differentiates squamous from non-squamous, non-small cell lung cancer (NSCLC) patients. When administered targeted therapy, whether currently available or under development, patients with squamous cell carcinoma of the lung have demonstrated varying response patterns ranging from a high incidence of severe or fatal internal bleeding in the lungs to overall poor response to treatment. Current methods for differentiating squamous from non-squamous non-small cell lung cancer are not standardized, are difficult to reproduce and have low accuracy.miRview squamousproduces a single score that indicates whether a sample is squamous or non squamous NSCLC.
  • miRview™ mesoThis test leverages microRNA’s high specificity as biomarkers to differentiate mesothelioma, a cancer connected to asbestos exposure, from other carcinomas in the lung. As mesothelioma patients require specific treatment regimens, an accurate diagnosis is critical. Currently, there is no single diagnostic test that is entirely conclusive for this differentiation. In addition, pathological diagnosis may suffer from significant inter-observer variability, and in the absence of a single specific and reliable marker mesothelioma can be difficult to identify from other cancers.miRview™ meso is a highly accurate test that may also assist physicians to rule out mesothelioma in patients diagnosed with adenocarcinoma in the lung who have been exposed to mesothelioma-related substances, primarily asbestos particles and heavy metals.

About microRNAs

MicroRNAs (miRNAs) are recently discovered, small RNAs that act as master regulators of protein synthesis, and have been shown to be highly effective biomarkers. MicroRNAs’ unique advantage as biomarkers lies in their high tissue specificity, and their exceptional stability in the most routine preservation methods for biopsies, including Formalin Fixed Paraffin Embedded (FFPE) block. It has been suggested that their small size (19-21 nucleotides) enables them to remain intact in FFPE blocks, as opposed to messenger RNA (mRNA), which tends to rapidly degrade in samples preserved by this method. In addition, early preclinical data has shown that by controlling the levels of specific microRNAs, cancer cell growth may be reduced. To learn more about microRNAs, please visit www.rosettagenomics.com.

About miRview™ Products

miRview™ are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview™ mets accurately identifies the primary tumor site in metastatic cancer and Cancer of Unknown Primary (CUP). miRview™ squamous accurately identifies the squamous subtype of non small cell lung cancer (NSCLC), which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain therapies. miRview™ meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview™ tests are designed to provide objective diagnostic data; it is the treating physician’s responsibility to diagnose and administer the appropriate treatment. In theUS alone, over 100,000 patients a year may benefit from the miRview™ mets test, 60,000 from miRview™ squamous, and 60,000 from miRview™ meso, with similar numbers of patients outside theUS. The company’s tests are now being offered through distributors around the globe. For more information, please visit www.mirviewdx.com.

About Rosetta Genomics

Rosetta Genomics (NASDAQ:ROSG - News) is a leading developer of microRNA-based molecular diagnostics. Founded in 2000, the company’s integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong IP position and proprietary platform technologies, Rosetta Genomics is working on the application of these technologies in the development of a full range of microRNA-based diagnostic tools. The company’s first three microRNA-based tests, miRview™ squamous, miRview™ mets, and miRview™ meso, are commercially available through its Philadelphia-based CLIA-certified lab. Rosetta Genomics is the 2008 winner of Wall Street Journal’s Technology Innovation Awards in the medical/biotech category. To learn more, please visit www.rosettagenomics.com.

About Genetic Technologies Limited

Genetic Technologies (ASX:GTG - News) (NASDAQ Global Market: GENE) specializes in licensing, genetic testing and research. GTG’s exclusive access to a wide range of genetic tests enables it to expand its testing services throughout the Asia-Pacific region. The Company is the leading private provider of molecular diagnostics for cancer susceptibility inAustralia and is seeking to build on this position through strategic relationships. GTG’s pipeline of innovative research projects will potentially add considerable further value to its licensing and genetic testing businesses.

Forward-Looking Statement Disclaimer

Various statements in this release concerning Rosetta’s future expectations, plans and prospects, including without limitation, statements relating to the role of microRNAs in human physiology and disease, the potential of microRNAs in the diagnosis and treatment of disease, and Rosetta’s expected expansion of its global distribution network constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: Rosetta’s approach to discover microRNA technology and to work on the application of this technology in the development of novel diagnostics and therapeutic tools, which may never lead to commercially accepted products or services; Rosetta’s ability to obtain, maintain and protect its intellectual property; Rosetta’s ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta’s need and ability to obtain additional funding to support its business activities; Rosetta’s dependence on third parties for development, manufacture, marketing, sales, and distribution of products; Rosetta’s ability to successfully develop its candidate tools, products and services; Rosetta’s ability to obtain regulatory clearances or approvals that may be required for its products and services; the ability to obtain coverage and adequate payment from health insurers for the products and services comprising Rosetta’s technology; competition from others using technology similar to Rosetta’s and others developing products for similar uses; Rosetta’s dependence on collaborators; and Rosetta’s short operating history; as well as those risks more fully discussed in the "Risk Factors" section of Rosetta’s Annual Report on Form 20-F for the year ended December 31, 2008 as filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent Rosetta’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.

http://finance.yahoo.com/news/Rosetta-Genomics-Names-bw-1494028405.html?x=0&.v=1

 
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Mesothelioma Patients Sought for Clinical Trial

Monday, September 14, 2009

Researchers are seeking 40 patients that have confirmed malignant mesothelioma, who are not candidates for surgery or radiation, to test the drug gefitinib. Gefitinib inhibits cellular growth in cancerous cells by targeting the proteins. The trade name for gefitinib is Iressa.

Malignant mesothelioma is a cancer caused by exposure to airborne asbestos fibers. The fibers are either inhaled or swallowed then travel through the body becoming lodged, resulting in cancer decades later. Often called “asbestos cancer,” mesothelioma is resistant to many current treatments. Currently there is no known cure for mesothelioma, and the average survival time varies from 4 - 18 months after diagnosis.

The study, conducted by researchers at the National Cancer Institute inBethesda,Maryland, is a Phase II clinical trial to determine the efficacy of the drug for mesothelioma patients. Currently, the drug is used for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), and who have previously been treated with chemotherapy.

Patients involved in the study will receive daily doses of oral gefitinib while being monitored. Clinicians will follow study participants for up to four years.

Gefitinib Clinical Trial

http://www.mesotheliomahelp.net/blog/2009/09/mesothelioma-patients-sought-for.asp

 
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Super Religare Laboratories Ties up with Rosetta

September 2009 - expresshealthcaremgmt.com

Rosetta's miRview tests can offer patients and physicians new insights on cancer

Rosetta Genomics, Limited, a leading developer of microRNA-based molecular diagnostics, and Super Religare Laboratories Limited (SRL),India's largest diagnostics network, recently announced that they have signed an exclusive distribution agreement for Rosetta Genomics' three currently-available diagnostic tests. Under the agreement, SRL will market Rosetta Genomics' miRview tests inIndia,Saudi Arabia,Qatar, and the UAE. Samples will be sent from SRL's territories to Rosetta Genomics' Philadelphia-based CLIA-certified laboratory for analysis. The agreement also envisages joint cooperation and collaboration between the two companies to conduct field trials for development of tests and assays an exchange of information for development of new technologies and leading edge diagnostic solutions. The Rosetta Genomics tests that will be distributed by SRL inIndia include miRview mets (to accurately identify the primary tumor site in patients with metastatic cancer); miRview squamous (this differentiates squamous from non-squamous, non-small cell lung cancer (NSCLC) patients) and miRview meso (to differentiate mesothelioma, a cancer connected to asbestos exposure, from other carcinomas in the lung).

EH News Bureau

http://www.expresshealthcaremgmt.com/200909/market21.shtml

 
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OxfordUniversity improves asbestos cancer tests

2009-08-27 00:50:34 (GMT) (JusticeNewsFlash.com - Justice News Flash, Mesothelioma Asbestos)

New asbestos related cancer testing discovered
A team of scientists atOxfordUniversity announce the development of a better diagnostic test for asbestos related mesothelioma lung cancer. The asbestos testing study was recently published in the American Journal of Respiratory and Critical Care Medicine.

New York mesothelioma cancer injurynews-OxfordUniversity researchers develop better testing for fatal cancer related to asbestos exposure.

New York,NY–Mesothelioma lung cancer experts in theUnited Kingdom are hopeful with the development of a more rapid test for the diagnosis of asbestos exposure related cancer. As reported by BBC news on Monday, a team of scientists atOxfordUniversity http://www.ox.ac.uk/ the oldest University in the English-speaking world located inOxford,Oxfordshire,United Kingdom, claim they have developed a more sensitive test for diagnosing asbestos related mesothelioma cancer.

Mesothelioma is a fatal cancer with no known cure. It is typically caused by primary and/or secondary exposure to asbestos fibers. Mesothelioma lung cancer presents on the lung surface and does not respond to chemotherapy. Mesothelioma cancer is a disease found in workers, residents, and consumers who have inhaled aerated asbestos laden dust fibers. Mesothelioma usually takes decades to develop after the initial exposure and is found in workers in various industries including; factories, mining, construction, Naval, shipyards, and other fields. Once the lung cancer has developed, the life expectancy is twelve months or less with medical experts focusing on symptom management since there is no known cure.

Currently, retired workers, laborers, residents, and consumers who present with respiratory symptoms have to go through a series of tests, some quite invasive, before a confirmed diagnosis of mesothelioma cancer can be determined by doctors and surgeons. Suffering patients are unable to file a claim with worker’s compensation until the diagnosis is confirmed. With a life expectancy of less than 12 months once a person is afflicted with the fatal disease, the quicker a patient suffering with respiratory symptoms, related to mesothelioma lung cancer is diagnosed, the better quality of life they may have in their final days.

New York mesothelioma cancer injury information by Heather L. Ryan legal news reporter.

http://www.justicenewsflash.com/2009/08/27/oxford-university-improves-asbestos-cancer-tests_200908271991.html

 
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'Better' test for asbestos cancer

Monday, 24 August 2009

Scientists claim they have developed a more sensitive test for the asbestos-related cancer mesothelioma.

The cancer develops long after exposure to asbestos but patients usually have a limited life expectancy.

The test developed by a team atOxfordUniversity looks at levels of a protein closely linked to the cancer in fluid around the lungs.

AUK lung expert welcomed the American Journal of Respiratory and Critical Care Medicine study.

A simple test which can exclude the diagnosis without resort to more invasive methods would be welcomed

Dr Paul Beckett, British Thoracic Society

Mesothelioma is an invariably fatal tumour found in the surface of the lung. While relatively rare, it is very difficult to treat because of its location and because it does not seem to respond well to chemotherapy.

The disease has been found in people with no history of exposure to asbestos, but inhaling the dust released by the mineral when it is broken up is known to be a key risk factor.

It has particularly affected tradesmen such as joiners, plumbers and electricians.

Because it can take many decades for the disease to develop, experts expect the number of cases in theUK to peak at around 2,200 by 2013.

Laws preventing occupational exposure to asbestos are in place in the developed world. There are no such restrictions in developing countries, however.

High levels

The researchers focused on ways of distinguishing mesothelioma as a cause of pleural effusion, the build-up of fluid in the pleural cavity surrounding the lungs.

There are many causes of this symptom, many of which are benign or linked to other types of cancer but over 90% of people with mesothelioma have the symptom.

At the moment, doctors carry out pleural fluid cytology - a lab test which looks for cancerous cells.

However theOxford team say this is not a very sensitive test.

Team members used pleural fluid samples from over 200 patients who had been referred to a specialist respiratory clinic.

They then looked at levels of the protein meothelin - which is released in high quantities in the pleural fluid of most patients with mesothelioma.

It was found that levels of the protein were almost six times higher in patients with the cancer than in those with secondary lung cancers, and 10 times greater than those with benign conditions.

Rapid diagnosis

Dr Helen Davies, who worked on the research, said: "This study suggests a way for clinicians to more readily identify cases of mesothelioma from the start."

She added: "Because mesothelioma has a median survival time of 12 months, minimising the number of invasive procedures and tests patients require is crucial to reduce morbidity and the time they need to spend in hospital.

"An earlier diagnosis also allows speedier interventions to relieve symptoms as well as initiation of other treatments such as chemotherapy or radiotherapy if appropriate.

"Claims for worker's compensation may also be instigated once the diagnosis is confirmed."

Dr Paul Beckett of the British Thoracic Society said: "A simple test which can exclude the diagnosis without resort to more invasive methods would be welcomed, allowing a more streamlined diagnostic pathway both for those with and without the disease.

"Such a pathway would be expected to lead to more rapid diagnosis and therefore treatment and perhaps improve the outlook for this disease, as well as avoiding unnecessary tests in those who don't have mesothelioma."

Professor Stephen Spiro, of the British Lung Foundation, said: "This study is an important step forward, as it could lead to earlier diagnosis and better treatment of mesothelioma which is vital as currently most patients diagnosed with this disease live less than 12 months."


http://news.bbc.co.uk/2/hi/health/8214847.stm

 
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Clinical Trials: The Bridge to Medical Innovation

Most people don't think about the origins of the drug they buy at the local pharmacy or the inspiration behind the medical procedure they undergo at their neighborhood hospital. Yet every pill, every diagnostic image, every surgical procedure–medical treatment in any shape or form–stems from a single source: research. Medical innovations start with the ideas and visions of committed scientists. Successful innovations then evolve over time–not weeks or months, but years–graduating through the different stages of development: basic research, translational research, and clinical research.

"Basic research, done in labs, involves studying how cells work, how they talk to each other, how they know what to do, and what conditions and drugs make their functions more or less efficient. Here, scientists first test new treatments in animals to find out if they might be helpful or harmful to people," explains Henry M. Spotnitz, MD,George H. Humphreys II Professor of Surgery at Columbia University College of Physicians & Surgeons andVice Chairman for Research and Information Systems at the Department of Surgery.

Translational research bridges scientific discovery to clinical delivery—whether by bringing tools out of the laboratory and delivering them to the patient, or by taking techniques and findings from the clinical setting back to the laboratory for evidenced-based practice. "The process of identifying drugs, devices, or treatments that should be developed, funding and conducting the development, and putting the therapy in the hands of clinical investigators is the essence of translational research," Dr. Spotnitz continues.

Clinical trials, also known as clinical research, are the furthest progression from the basic research lab. In clinical trials, scientists apply their discoveries to humans, testing new drugs, devices, or innovative therapies in selected patients.

What is a Clinical Trial?

Clinical trials are the bridge over which all new medical therapies must pass to become accepted practice—and the bridge is a long one. For patients, clinical trials can typically last for a few weeks or months. For scientists, they can continue on for years before a new therapy may see the light of day.

There are different types of clinical trials: treatment, prevention, diagnostic, screening, and quality of life trials—and the trials are conducted in progressive phases (I-IV). Once a clinical trial reaches the end of the bridge–proving its potential worth as a medical therapy–the Food and Drug Administration (FDA), a government agency, must officially approve the therapy for medical consumers.

For patients, participation in a clinical trial is voluntary. Common reasons for joining a clinical trial include: playing a more active role in your own health care; gaining access to innovative treatments before they become widely available; and helping others by contributing to advancements in medical research.

How Do Clinical Trials Work?

To ensure that no one can influence the results of a study, clinical trials employ a range of specialized testing mechanisms intended to prevent bias and provide reliable results:

  • Prospective Trials—Patients are identified and then followed over time.
  • Randomized Trials—Patients are grouped by chance into (typically) a treatment group and a control group (also called a placebo group). A control group receives either the current standard treatment or a placebo-an inactive pill or liquid. The results of the control group are then compared with those of the treatment group.
  • Cross-over Trials—Patients receive both the treatment and the placebo at different times, with careful monitoring of their responses to both approaches.
  • Double-blinded Trials—Neither the patient nor the researcher knows if the patient is receiving the treatment or the placebo.

In addition, some clinical trials are calledopen label studies, because both the patient and the researcher know that the patient is receiving the treatment and not the placebo.

By federal regulation, every clinical trial in theUnited States must be approved and monitored by an Institutional Review Board (IRB), an independent committee of physicians, statisticians, community advocates, and others. The IRB is charged with ensuring that all clinical trials within a given medical institution are ethical and that the rights of the participants in those trials are protected.

Clinical trials retain very specific participation guidelines. Establishing and maintaining these guidelines is a critical part of producing meaningful and reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria," while those that disallow someone are called "exclusion criteria." Typical criteria include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

What are the Different Types of Clinical Trials?

  • Treatment Trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
  • Prevention Trials look for better ways to prevent a given disease in people who have never had that disease or to prevent a disease from returning. Preventative approaches include medicines, vitamins, vaccines, minerals, and lifestyle changes.
  • Diagnostic Trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
  • Screening Trials test the best way to detect certain diseases or health conditions.
  • Quality of Life Trials (or supportive care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

What are the Phases of Clinical Trials?

Clinical trials are conducted in phases. Each phase of a trial has a different purpose and helps scientists to answer specific questions.

While small, early phase trials may be conducted by individuals or small groups of physicians, larger trials are typically conducted by hospitals, pharmaceutical companies, or device manufacturers. If a therapy successfully passes through phase III trials, the FDA may approve it to be marketed to the public.

Phase

Definition

Phase I Trials

Researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase II Trials

The study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

Phase III Trials

The study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase IV trials

Post-marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

The Challenges and Rewards

The importance of clinical trials to the advancement of modern medicine cannot be overstated. Clinical trials partner scientists, patients, and industry in a journey that may improve medical treatments and, in some cases, lead to spectacular medical breakthroughs. Dr. Spotnitz emphasizes that the journey is long, costly, and sophisticated, but also represents the core mission of dedicated physician-scientists.

"Clinical research differentiates us from routine practice. It allows us to offer the best-known therapies and diagnostic tests to patients and to achieve superior clinical results," says Dr. Spotnitz. "Today, our potential to help patients is limited primarily by our ability to assimilate this flood of information and imagine innovative ways to apply it. Also, research is heavily dependent on financial support from the government, industry, and philanthropy. Raising money for research is highly competitive and is one of the challenges all scientists face."

As to the rewards of medical research in general, Dr. Spotnitz is quick to answer. "There is nothing more exciting to a dedicated scientist than making a new discovery. To imagine a solution to an important problem, to actually solve the problem, and to use that solution to help patients is an almost unimaginable thrill. The best thing about research is the sense that you are doing something that is important to other human beings, and that makes the journey–and struggles along the way–certainly worth the effort."

http://www.columbiasurgery.org/pat/research/info.html

 
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Clinical Trial to Compare Survival Rates, Quality of Life in Mesothelioma Patients

Phase III trial to measure outcome of talc pleurodesis and video-assisted thorascopic cytoreductive pleuroectomy

Syracuse,NY 8/13/2009 06:35 PM GMT (FINDITT)

 

Researchers atPapworthHospital and several other medical facilities inGreat Britain are enrolling participants in a Phase III clinical trial to compare the efficacy of talc pleurodesis to a minimally invasive surgical procedure, called video-assisted thorascopic (VAT) cytoreductive pleurectomy, in patients with malignant mesothelioma.

 

This phase of the study is designed to determine if either technique is associated with higher one-year survival rates, and is also designed to determine if either technique offers better control of pleural effusion, a condition which causes a build up of fluid around the lungs.

 

Both techniques are currently used in mesothelioma treatment, and are designed to target the pleura, the membrane or sac which surrounds the lungs. In men and women with pleural mesothelioma, fluid often collects in the pleural area, interfering with normal breathing. In talc pleurodesis, the surgeon injects talc between the two layers of the pleura, irritating them and causing them to adhere to each other, and closing the pleural space where fluid builds up.

 

Cytoreductive pleurectomy involves the partial or complete removal of the pleural membrane using a surgical technique. The procedure can be performed through an open chest incision, or by using the VAT technique, a minimally invasive procedure which gained widespread popularity in the 1990s. This methoduses small incisions to access the chest cavity, allowing insertion of tiny cameras as well as surgical intruments. Surgeons are able to both view the chest cavity and perform certain surgical procedures through these tiny incisions, resulting in fewer side effects and less downtime than traditional “open” procedures requiring large incisions.

 

Other secondary outcomes being compared during the trial include procedure-related complications; quality of life at 3-, 6-, and 12-month intervals; and overall healthcare-associated costs. Men and women with diagnosed or suspected mesothelioma may be selected to participate in the trial as long as they have never undergone an attempted pleurodesis procedure in the past.

 

In qualifying patients, the VATS or pleurodesis procedure may be performed at the time of biopsy or once diagnosis has been confirmed.

 

Researchers hope to enroll 196 patients in the trial. In addition to the primary location at Papworth, hospitals inLondon, Basildon, Sheffield, andLeicester are also participating in the study.

 

PapworthHospital, located inCambridgeshire,England, is the largest cardiothoracic center in theUK, and also serves as theUK’s main organ transplant facility. Dr. Robert Winter, an adult respiratory medicine specialist and mesothelioma cancer clinical researcher, practices medicine at Papworth and also serves as the Medical Director for the UK National Health Service [NHS] for theEastern England division, a position he has held since January 2008.

 

Mesothelioma is a rare form of cancer that affects the mesothelium, the membrane that surrounds the body’s internal organs. The most common type of mesothelioma, pleural mesothelioma, affects the membrane surrounding the lungs. Mesothelioma cancer can also occur in the abdominal cavity and the membrane surrounding the heart. These conditions are referred to as peritoneal mesothelioma and pericardial mesothelioma, respectively.

 

The development of mesothelioma cancer is associated with exposure to asbestos, developing after tiny inhaled particles of asbestos are inhaled or ingested, lodging in the chest or abdominal cavity. These particles cause genetic changes in the cells of the mesothelium over time. Symptoms of mesothelioma may not become apparent until years- even decades – after exposure to the mineral, and include persistent cough, chest pain, and shortness of breath.

 

For many years, asbestos was a part of literally thousands of products in the construction, shipbuilding, automotive, and HVAC industries, and is still present in millions of homes, buildings, and ships. In the mid-1980s, legislation was passed banning the use of asbestos in the manufacturing process. However, frequent exposure to the fibers still occurs as materials containing the product degrade over time. As a result, even simple home renovation tasks can put individuals at risk for exposure.

 

For patients outside of the United States who are interested in learning more about this clinical trial or the mesothelioma treatment options available at Papworth Hospital, please visit http://www.papworthhospital.nhs.uk/ or call the hospital directly: 01480 830541.

http://www.transworldnews.com/NewsStory.aspx?id=110238&cat=11

 
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CBP501 Enters Phase II Trials for the Treatment of Non-Small Cell Lung Cancer

Tue Jul 7, 2009 2:01am EDT

 

NUMAZU,Japan &OSAKA,Japan&CAMBRIDGE,Mass.--(Business Wire)--
CanBas Co., Ltd. (Numazu,Shizuoka, "CanBas") and Takeda Pharmaceutical Company
Limited (Osaka, "Takeda") together with Takeda`s wholly-owned subsidiary
Millennium: The Takeda Oncology Company (Cambridge,MA, "Millennium") today
announced the advancement of CBP501 into Phase II clinical trials for the
treatment of patients with non-small cell lung cancer (NSCLC). Current
pre-clinical data suggest that CBP501 has the potential to induce cancer cell
death through a mechanism of action that blocks the ability of cancer cells to
transition through the cell cycle. Data from a previous Phase I study indicate
that CBP501 may enhance anti-cancer cytotoxic activity when combined with
selected chemotherapeutic drugs.
 
CanBas and Takeda signed a collaboration agreement in March 2007 for the
development of investigational compounds to treat patients with cancer,
including CBP501 and its backup compounds discovered by CanBas. Under the terms
of this agreement, the worldwide exclusive rights for development, manufacturing
and marketing have been granted to Takeda, while in theU.S. the development and
promotion are jointly conducted by both companies. Millennium will work with
CanBas to advance global development expeditiously. In November 2008, the
companies initiated a Phase II trial of CBP501 in malignant pleural
mesothelioma.
 
"CanBas is committed to creating important new treatments for cancer. We are
excited to see CBP501 moving to Phase II trials in non-small cell lung cancer,"
said Takumi Kawabe, M.D., Ph.D., President and CEO, CanBas. "This is the second
Phase II trial for CBP501, and we look forward to advancing both indications
toward an eventual marketing authorization."
 
"We are encouraged by the continued progress of CBP501," said Anthony Boral,
Vice President, Oncology Clinical Research, Millennium. "Through our partnership
with CanBas, we will continue to use our understanding of cancer biology to
identify new strategies to fight cancer and bring hope to patients."
 
About CanBas
 
CanBas was spun off of the research of three scientists from theNagoyaCity
MedicalSchool andFujitaHealthMedicalSchool. These scientists founded CanBas
as a drug development biotech with the help of angels and venture capitalists in
2000. Additional information is available through its corporate website,
www.canbas.co.jp.
 
About Takeda
 
Located inOsaka,Japan, Takeda is a research-based global company with its main
focus on pharmaceuticals, enhancing its R&D pipeline through in-house research
and development, lifecycle management of existing products, and also alliance
and in-licensing. As the largest pharmaceutical company inJapan and one of the
global leaders of the industry, Takeda is committed to striving toward better
health for individuals and progress in medicine by developing superior
pharmaceutical products. Additional information about Takeda is available
through its corporate website, www.takeda.com.
 
About Millennium
 
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company
based inCambridge,Mass., markets VELCADE® (bortezomib)for Injection, a
first-in-class proteasome inhibitor, and has a robust clinical development
pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by
Takeda Pharmaceutical Company Ltd. in May, 2008. The Company`s research,
development and commercialization activities are focused in oncology. Additional
information about Millennium is available through its website,
www.millennium.com.
 
Photos/Multimedia Gallery Available:
http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5997630⟨=en

http://www.reuters.com/article/idUS51112+07-Jul-2009+BW20090707

 
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Combining Immunotoxin and Chemotherapy for Pleural Mesothelioma

Name of the Trial -July 14, 2009 • Volume 6 / Number 14

Phase I Study of SS1(dsFv)-PE38 Immunotoxin in Combination with Pemetrexed Disodium and Cisplatin in Patients with Unresectable Malignant Epithelial Pleural Mesothelioma (NCI-08-C-0026).

Dr. Raffit HassanDr. Raffit Hassan

Principal Investigator
Dr. Raffit Hassan,NCICenter for Cancer Research

Why This Trial Is Important
Malignant mesothelioma is a rare cancer that affects the tissue lining the chest (pleura) or the abdomen (peritoneum). Based on the appearance of the cancer cells under a microscope, mesothelioma is classified as epithelial, sarcomatoid, or mixed; epithelial mesothelioma is associated with slightly better outcomes than the other types.

Patients with pleural mesothelioma (mesothelioma of the pleura) that cannot be removed by surgery (unresectable or inoperable) are usually treated with combination chemotherapy using the drugs pemetrexed and cisplatin. Although this therapy can delay progression of the disease, the benefits are often short lived and most patients die within 2 years.

Researchers hope an experimental immunotoxin called SS1(dsFv)-PE38 (or SS1P) can improve the outcomes of patients with unresectable mesothelioma. SS1P is a genetically engineered biological agent in which part of a bacterial toxin is linked to an antibody that recognizes the protein mesothelin. Mesothelin is found in abundance on the surface of epithelial mesothelioma cells and cells of several other types of cancer. In laboratory studies, combining SS1P with chemotherapy leads to increased antitumor activity compared with either therapy alone.

In this trial, patients with inoperable epithelial pleural mesothelioma will be given SS1P in combination with pemetrexed and cisplatin. The dose of SS1P will be increased in consecutive groups of 3–6 patients until the maximum tolerated dose is reached. Researchers will also study any side effects of this combination treatment and examine how SS1P is broken down by the body.

“Mesothelin is highly expressed in epithelial malignant mesothelioma, making it a good target for tumor-specific therapy with SS1P,” said Dr. Hassan. “Given the marked synergy between SS1P and chemotherapy in preclinical studies, combining them could potentially result in increased antitumor activity in patients.” 

For More Information

See the list of entry criteria and trial contact information or call the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The call is toll-free and confidential.

http://www.cancer.gov/ncicancerbulletin/071409/page6

 
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Ranpirnase Added to Doxorubicin Improves Survival in Pretreated Patients With Malignant Mesothelioma: Presented at ASCO

By Emma Hitt, PhD

ORLANDO, Fla -- June 2, 2009 -- Ranpirnase added to doxorubicin improves survival in pretreated patients with malignant mesothelioma, according to findings from a phase 3 trial presented here on June 1 at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO).

According to the researchers, a previous study has demonstrated that ranpirnase, a novel ribonuclease, resulted in a 1-year survival rate of 42% in a multicentre phase 2 trial in chemotherapy-naïve and pretreated patients.

Martin Reck, MD, Hospital Grosshansdorf,Hamburg,Germany, and colleagues compared the efficacy and safety of doxorubicin with or without ranpirnase. Patients (n = 413) had unresectable malignant mesothelioma and an Eastern Cooperative Oncology Group performance status of 0 to 1, and they were allowed to have up to 1 previous line of treatment. Mean age was approximately 62 years.

An intent-to-treat analysis found no significant difference in median overall survival. With doxorubicin plus ranpirnase, the median survival was 11.1 versus 10.7 months for doxorubicin plus placebo (hazard ratio [HR] = 1.02; 95% confidence interval [CI], 0.82-1.26).

However, in a preplanned analysis of 130 patients who had been pretreated with chemotherapy, a significant advantage in survival in favour of doxorubicin plus ranpirnase was noted, with a median survival of 10.5 months for ranpirnase versus 9 months for placebo (HR = 1.49; 95% CI, 1.02-2.17).

No adverse safety issues were observed with the addition of ranpirnase. The most common side effects were associated with doxorubicin and included nausea, fatigue, and alopecia. Other side effects included neutropenia, oedema, arthralgia, and peripheral neuropathy.

The researchers concluded that the treatment is safe and feasible and may result in a significant impact on survival compared with doxorubicin alone for pretreated patients.

"Further evaluation of ranpirnase in combination with pemetrexed and confirmation of second-line efficacy will be of interest," Dr. Reck said during the presentation.

[Presentation title: Randomized, Multicenter Phase III Study of Ranpirnase Plus Doxorubicin (DOX) Versus DOX in Patients With Unresectable Malignant Mesothelioma (MM). Abstract 7507]

http://www.docguide.com/news/content.nsf/news/852571020057CCF6852575C90067E2AB

 
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The clinical trials of mesothelioma - their purpose and benefits

2009-07-05 02:40:58 (GMT) (mesotheliomacancernews.com - Mesothelioma News)

The purpose of the clinical trials is to find cures and ways of better treatment of different diseases, such as mesothelioma and asbestosis. These are the diseases for which, no cure has been found so far. So many families get deprived from their loved ones, when after diagnosis, they close their eyes and pass away suddenly, but helplessly, in a year or two.

Researchers continue their study, and the discovered drugs are first tried on different animals. If the results are promising, mesothelioma patients are requested to come forward and volunteer for the clinical trials.During these clinical trials , keen observation is made to keep a check on the safety and effectiveness of the drug being administered to the volunteer patients

The purpose of treating the patient with the newly invented drug is to provide a better forms of treatment than the traditional ones, and also to find a way for the cancer prevention.

This research in the clinical trials is evaluated in different stages, called as phases. These phases are from phase ‘ trial one’ to phase’ trial four.’ Beginning from phase one, and advancing up to the final stage, these phases are described in detail as follows:

!) Phase Trial one. In this phase, a series of tests are done to determine, how the new drug has to be administered, The safety of the drug is evaluated, considering its side effects.
In this phase, the study group is small, ranging from 20 to thirty participants.

1) Phase Trial two: Once the safety of a drug is established, it is compared to the treatments of the previous drugs to observe and check its effectiveness on a single disease or on a group of diseases. The main purpose is to learn the effectiveness of the new drug for a specific application. A larger group of about 300 volunteer patients of mesothelioma participates in this phase.

3) Phase Trial three: This is the final step, before the drug can be approved by the concerned authorities. The research confirms the effectiveness of the drug on the mesothelioma patients, keenly observing the side effects, and comparing the drug with the existing drugs for a better evaluation. Larger groups of 1000 to 3000 participants help the research to continue towards success.

4) Phase Trial Four: Post marketing studies are the main feature of this phase. In order to ensure patients’ safety, exploration continues through medication, surgery and other therapies, and the alternative therapy.

During the research work from phase one to phase four, the treatment options keep on varying, depending upon the diagnostic features. The advantage of this participation, helps the patient to become more active, by understanding the new techniques, discussing the research technology with his fellow volunteers and the scholars

http://www.mesotheliomacancernews.com/2009/07/04/clinical-trials-mesothelioma-purpose-benefits_20090704206.html

 
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CBP501 Enters Phase II Trials for the Treatment of Non-Small Cell Lung Cancer

Tue Jul 7, 2009 2:01am EDT

 

NUMAZU,Japan &OSAKA,Japan&CAMBRIDGE,Mass.--(Business Wire)--
CanBas Co., Ltd. (Numazu,Shizuoka, "CanBas") and Takeda Pharmaceutical Company
Limited (Osaka, "Takeda") together with Takeda`s wholly-owned subsidiary
Millennium: The Takeda Oncology Company (Cambridge,MA, "Millennium") today
announced the advancement of CBP501 into Phase II clinical trials for the
treatment of patients with non-small cell lung cancer (NSCLC). Current
pre-clinical data suggest that CBP501 has the potential to induce cancer cell
death through a mechanism of action that blocks the ability of cancer cells to
transition through the cell cycle. Data from a previous Phase I study indicate
that CBP501 may enhance anti-cancer cytotoxic activity when combined with
selected chemotherapeutic drugs.
 
CanBas and Takeda signed a collaboration agreement in March 2007 for the
development of investigational compounds to treat patients with cancer,
including CBP501 and its backup compounds discovered by CanBas. Under the terms
of this agreement, the worldwide exclusive rights for development, manufacturing
and marketing have been granted to Takeda, while in theU.S. the development and
promotion are jointly conducted by both companies. Millennium will work with
CanBas to advance global development expeditiously. In November 2008, the
companies initiated a Phase II trial of CBP501 in malignant pleural
mesothelioma.
 
"CanBas is committed to creating important new treatments for cancer. We are
excited to see CBP501 moving to Phase II trials in non-small cell lung cancer,"
said Takumi Kawabe, M.D., Ph.D., President and CEO, CanBas. "This is the second
Phase II trial for CBP501, and we look forward to advancing both indications
toward an eventual marketing authorization."
 
"We are encouraged by the continued progress of CBP501," said Anthony Boral,
Vice President, Oncology Clinical Research, Millennium. "Through our partnership
with CanBas, we will continue to use our understanding of cancer biology to
identify new strategies to fight cancer and bring hope to patients."
 
About CanBas
 
CanBas was spun off of the research of three scientists from theNagoyaCity
MedicalSchool andFujitaHealthMedicalSchool. These scientists founded CanBas
as a drug development biotech with the help of angels and venture capitalists in
2000. Additional information is available through its corporate website,
www.canbas.co.jp.
 
About Takeda
 
Located inOsaka,Japan, Takeda is a research-based global company with its main
focus on pharmaceuticals, enhancing its R&D pipeline through in-house research
and development, lifecycle management of existing products, and also alliance
and in-licensing. As the largest pharmaceutical company inJapan and one of the
global leaders of the industry, Takeda is committed to striving toward better
health for individuals and progress in medicine by developing superior
pharmaceutical products. Additional information about Takeda is available
through its corporate website, www.takeda.com.
 
About Millennium
 
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company
based inCambridge,Mass., markets VELCADE® (bortezomib)for Injection, a
first-in-class proteasome inhibitor, and has a robust clinical development
pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by
Takeda Pharmaceutical Company Ltd. in May, 2008. The Company`s research,
development and commercialization activities are focused in oncology. Additional
information about Millennium is available through its website,
www.millennium.com.
 
Photos/Multimedia Gallery Available:
http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5997630⟨=en

http://www.reuters.com/article/idUS51112+07-Jul-2009+BW20090707

 
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Gene Tests can provide More Information about Mesothelioma Patients

Posted on June 12th, 2009

by Deon Scott in All News

According to a recently published report a type of gene testing could help to determine certain information about mesothelioma patients. The results of a study were recently published in the Journal of the National Cancer Institute, with officials claiming that this certain type of gene testing could determine a couple of important factors.

The gene testing that is at the centre of the study involves looking at the ratios of four genes. Researchers involved in the study have claimed that this type of testing can help to predict the survival odds for mesothelioma patients, enabling medics to work out which patients have the best chances of survival.

Another thing that this type of gene testing can apparently help with is to help determine which mesothelioma patients are likely to make the best candidates for surgery. This could help in the treatment of patients that have this form of cancer, which is notoriously difficult to diagnose and treat.

The report stated: “Patients whose gene ratio test results predict a good prognosis after surgery may more confidently select the treatment option that includes surgery. Patients assigned to the predicted poor outcome group…could be counseled to forgo surgery, which would not benefit them, and to seek best supportive care.”

http://www.bloggernews.net/121205

 
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Mesothelioma Gene Test Predicts Survival Odds

Posted on Friday, June 05, 2009.

mesothelioma testA test that looks at ratios of four genes can accurately predict which mesothelioma patients face the greatest chance of survival, and help pinpoint the best candidates for surgery, according to a study in the May 6 Journal of the National Cancer Institute.

Mesothelioma is one of the most challenging cancers to treat. Patients survive an average of just one year after their diagnosis. Surgery can help improve survival somewhat, but it does have risks. Knowing which patients are most likely to benefit from surgery can spare those with a poor outlook from having to undergo an unnecessary and invasive procedure.

To predict a patient’s prognosis, doctors typically look at cancer stage (how far it has spread), whether the tumor can be removed surgically, the appearance of cells under a microscope (histological subtype), and whether the cancer has spread to the lymph nodes. However, often it is not possible for doctors to determine these factors without subjecting patients to invasive procedures. “Usually you need major surgery to determine the stage which can help predict outcome,” says Raphael Bueno, MD, Associate Chief in the Division of Thoracic Surgery and Director of the Thoracic Surgery Residency Program at Brigham and Women’s Hospital in Boston, Massachusetts.

Dr. Bueno’s team is currently investigating a less invasive way to predict a mesothelioma patient’s prognosis, using a method that analyzes differences in genes expressed by the cancer. Although two gene-based methods are available for predicting breast cancer recurrence, the technology hasn’t been widely used, in part because the tests use large arrays including thousands of genes, and the results are difficult to replicate between laboratories.

Dr. Bueno’s team has developed a much simpler test that predicts patient outcomes based on the ratios of just four genes. They selected the four genes by comparing the genes of mesothelioma patients who had good outcomes (longer survival times) to those of patients who had poor outcomes.

The current study was designed to determine the accuracy of this test in predicting the survival of mesothelioma patients who were undergoing surgery. Researchers analyzed tissue samples taken prospectively from 120 mesothelioma patients, and then followed-up the patients until 2007 or until their death.

Using the gene ratio test, the researchers assigned participants to two groups: a good outcome group, and a poor outcome group. Survival rates differed significantly between the two groups. Although the poor outcome group survived an average of just 9.5 months, the good outcome group survived almost double that—an average of 16.8 months.

The gene ratio test also proved easily repeatable, even when performed on the same specimens by different technicians using different instruments at different laboratories. The results also were reproducible using different tissue samples from the same patient’s tumor.

According to the authors, this minimally invasive test could be useful for mesothelioma patients who are considering surgery. “Patients whose gene ratio test results predict a good prognosis after surgery may more confidently select the treatment option that includes surgery,” the authors write. “Patients assigned to the predicted poor outcome group…could be counseled to forgo surgery, which would not benefit them, and to seek best supportive care.”

The researchers say they expect their gene test to improve survival among mesothelioma patients, preventing those who aren’t likely to benefit from surgery from having to undergo invasive procedures. However, further studies are needed to determine what effect this test will actually have on patient outcomes once it has been incorporated into the decision-making process.
 
Source:

Gordon GJ, Dong L, Yeap BY, Richards WG, Glickman JN, Edenfield H, Mani M, Colquitt R, Maulik G, Van Oss B, Sugarbaker DJ, Bueno R. Four-gene expression ratio test for survival in patients undergoing surgery for mesothelioma. Journal of the National Cancer Institute. 2009;101:678-686.

http://www.survivingmesothelioma.com/news/view.asp?ID=0034

 
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Ranpirnase Added to Doxorubicin Improves Survival in Pretreated Patients With Malignant Mesothelioma: Presented at ASCO

By Emma Hitt, PhD

ORLANDO, Fla -- June 2, 2009 -- Ranpirnase added to doxorubicin improves survival in pretreated patients with malignant mesothelioma, according to findings from a phase 3 trial presented here on June 1 at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO).

According to the researchers, a previous study has demonstrated that ranpirnase, a novel ribonuclease, resulted in a 1-year survival rate of 42% in a multicentre phase 2 trial in chemotherapy-naïve and pretreated patients.

Martin Reck, MD, Hospital Grosshansdorf,Hamburg,Germany, and colleagues compared the efficacy and safety of doxorubicin with or without ranpirnase. Patients (n = 413) had unresectable malignant mesothelioma and an Eastern Cooperative Oncology Group performance status of 0 to 1, and they were allowed to have up to 1 previous line of treatment. Mean age was approximately 62 years.

An intent-to-treat analysis found no significant difference in median overall survival. With doxorubicin plus ranpirnase, the median survival was 11.1 versus 10.7 months for doxorubicin plus placebo (hazard ratio [HR] = 1.02; 95% confidence interval [CI], 0.82-1.26).

However, in a preplanned analysis of 130 patients who had been pretreated with chemotherapy, a significant advantage in survival in favour of doxorubicin plus ranpirnase was noted, with a median survival of 10.5 months for ranpirnase versus 9 months for placebo (HR = 1.49; 95% CI, 1.02-2.17).

No adverse safety issues were observed with the addition of ranpirnase. The most common side effects were associated with doxorubicin and included nausea, fatigue, and alopecia. Other side effects included neutropenia, oedema, arthralgia, and peripheral neuropathy.

The researchers concluded that the treatment is safe and feasible and may result in a significant impact on survival compared with doxorubicin alone for pretreated patients.

"Further evaluation of ranpirnase in combination with pemetrexed and confirmation of second-line efficacy will be of interest," Dr. Reck said during the presentation.

[Presentation title: Randomized, Multicenter Phase III Study of Ranpirnase Plus Doxorubicin (DOX) Versus DOX in Patients With Unresectable Malignant Mesothelioma (MM). Abstract 7507]

 
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Current Status of Screening for Malignant Pleural Mesothelioma

Harvey I. Pass,MD,Michele Carbone, MD, PhD

Malignant mesothelioma is characterized by its association with asbestos, its long latency period, and the propensity for the diagnosis to be obtained in the later stages of the disease. Because the high-risk cohorts for mesothelioma are fairly well defined by the association with asbestos, and the exposure is usually in the workplace, it is hypothesized that early detection of the disease could (1) find patients at an earlier, more treatable stage and (2) result in prolonged survival over the present median 12 months from the start of therapy. Many studies have used standard chest X-ray to characterize changes associated with asbestos-exposed individuals, but the insensitivity of X-ray in screening patients with mesothelioma has never supported the wide-scale adaptation of such an effort. With the advent of computerized tomography, prospective trials, many of which are chiefly prevalence detection studies, have been performed and stress the importance for proper detailing by carefully qualifying suspicious changes, as well as defining the correct cohort to screen. Most recently, serum biomarkers with the potential to discriminate asbestos-exposed, non-cancer-bearing individuals from those with mesothelioma have been investigated both at single institutions and with multi-institutional-blinded trials. These markers, including soluble mesothelin-related protein, osteopontin, and megakaryocyte potentiating factor, may, in the future, be incorporated into a screening algorithm for high-risk asbestos-exposed individuals to help monitor these cohorts in a noninvasive fashion and guide the use of computerized tomography.

http://www.semthorcardiovascsurg.com/article/S1043-0679(09)00071-9/abstract

 
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Gene Expression Ratio Test Predicts Outcome In Mesothelioma Patients Treated With Surgery

ScienceDaily (Apr. 28, 2009) — A four-gene expression ratio test prospectively distinguished mesothelioma patients who had a statistically significant longer overall survival from those who had shorter survival in a single-institution study.

There are few effective treatment options available for patients with malignant pleural mesothelioma other than surgery. However, not all patients appear to derive benefit from surgery. Raphael Bueno, M.D., of the Brigham and Women's Hospital inBoston and colleagues showed in retrospective studies that measuring expression ratios of four genes could distinguish between those who have a good prognosis after surgery and those who have a poor prognosis.

In the current study, Bueno and colleagues tested the four-gene expression ratio test in 120 patients with mesothelioma who were treated at Brigham and Women's Hospital and participated in a prospective clinical trial. To evaluate the robustness and reproducibility of the test, the researchers evaluated the test on multiple tumor samples from each patient and used two different microarray platforms and two different biopsy techniques.

The test was able to predict overall survival after adjusting for other clinical factors. The test results were consistent for individual patients regardless of the techniques used for the test. When the researchers combined the gene ratio test results with known prognostic factors, they were able to separate patients into high-risk and low-risk groups. The median survival for patients in the high-risk group was 6.9 months compared with 31.9 months in the low-risk group.

"Patients whose gene ratio test results predict a good prognosis after surgery may more confidently select the treatment option that includes surgery," the authors write.

This research was published in the Journal of the National Cancer Institute on April 28, 2009.

http://www.sciencedaily.com/releases/2009/04/090428162014.htm

 
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Phase II of Clinical Trial began This Month

Posted on April 1st, 2009

by Deon Scott in All News

Earlier this month Phase II of a clinical trial relating to mesothelioma treatment. The aim of the study is to assess the effectiveness of an antibody in terms of slowing the growth of a protein that is found in excessive levels in tumors that are seen in mesothelioma patients. The protein is called mesothelin.

The Phase II trial has been initiated by a biopharmaceutical company, Morphotek Inc. The company is a subsidiary of Eisai Corporation ofNorth America. The trial into its MORAb-009 monoclonal antibody will assess the effects of the drug when combined with the chemotherapy drugs pemetrexed and cisplatin.

The treatment is aimed at seeing whether patients with advanced malignant pleural mesothelioma can continue survival without further progression of the disease as a result of the treatment. Nearly ninety participants were to take part in the trail, including those that had been diagnosed but had not yet received treatment.

As the trial began Chief Medical Officer of Morphotek Martin D. Phillips, M.D. stated: “We are excited to have initiated this Phase II study of MORAb-009 in mesothelioma in cooperation with leading physician-scientists.”

http://www.bloggernews.net/120287

 
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Mesothelioma Patients Look to New Clinical Trial

The drug CBP501 is being tested to develop new treatments for those suffering from malignant pleural mesothelioma

Syracuse,NY 3/16/2009 04:01 PM GMT (FINDITT)

 

CanBas Co. Ltd. is conducting a new study, CBP501 + Pemetrexed + Cisplatin in Patients With Sold Tumors (Phase I) and Patients With Pleural Mesothelioma (Phase II). Currently, the study, which began in May of 2008, is planned for completion in December of 2010. Approximately 72 people will participate in the study.

 

The phase I part of the study is to determine the correct dosage of CBP501 combined with full-does cisplatin and pemetrexed. The ideal candidate is a patient with histologically confirmed solid malignancy that must be metastatic or unresctable (unable to be removed by surgery). The patient cannot have standard curative or palliative measures or those measures must have become ineffective. Typically in this situation, the first-line therapy would have been the prescription of cisplatin and pemetrexed. To determine the maximum tolerated does (MTD) of CBP501 researchers will look at the DLTs occurring during the first treatment cycle. Pharmacokinetics of the three drugs will be reviewed during the first phase.

 

Phase II will evaluate the full-dose of cisplatin and pemetrexed combined with the MTD of CBP501 determined in Phase I. This will be tested with malignant pleural mesothelioma patients that have not yet been treated for their illness and tumors are not able to be removed by surgery.  The patients will be randomized into two different groups with a 2:1 ratio. The first group (Arm A) will receive pemetrexed, cisplatin and CBP501 while the second group (Arm B) will receive only pemetrexed and cisplatin. The randomization will be stratified by histology and performance status.

 

Cisplatin is an inorganic and water-soluble platinum complex. Once it undergoes hydrolysis it will react with DNA to produce intra and interstrand crosslinks. These crosslinks then impair replication and transcription of DNA. The toxins of cisplatin relate to the cellular arrest in the G2 phase of the cell cycle. Pemetrexed is a chemotherapy drug that has been commonly used to treat mesothelioma and non-small cell lung cancer.

 

Malignant pleural mesothelioma is a cancer of the pleura, a sac that contains the lungs and a thin membrane, the mesothelium. The membrane secretes a fluid that enables the lungs to expand and contract during breathing. Pleural mesothelioma is often developed after an exposure to asbestos where the airborne fibers are inhaled and become lodged in the soft lung tissue. Symptoms, such as chest pain, coughing or fluid around the lungs, can take between twenty and fifty years to appear, usually only in the late stages of the disease, making treatment difficult.

 

The study will be held inNevada,New Mexico,New York,Texas andPennsylvania. Anyone over the age of 18 who meets the criteria is eligible to participate. To learn more about the inclusion and exclusion criteria, please visit the case study’s website at: http://clinicaltrials.gov/ct2/show/NCT00700336?term=pleural+mesothelioma&rank=3.

 

For further information about mesothelioma cancer, please visit the Mesothelioma andAsbestosAwarenessCenter. TheMAACenter is accredited by the Health On The Net Foundation and is recognized as a reliable source of information by DisabilityInfo.gov.

  

Sources:

 

National Cancer Institute

 

ClinicalTrials.gov

http://www.transworldnews.com/NewsStory.aspx?id=79996&cat=15

 
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Over Forty Clinical Trials for Mesothelioma

Posted on Thursday, March 12, 2009.


ResearcherMesothelioma is still a difficult cancer to treat.  Today, there are at least 42 active clinical trials for mesothelioma, each trying to demonstrate a better treatment outcome than standard therapies.  While there are still trials of chemotherapy, radiation and surgery, today the emphasis is on newer therapies that can better target the tumor cells instead of indiscriminately harming cancer and healthy cells alike.  These better targeted therapies go by different names depending on the type and include terms like: anti-cytokine, antiangiogenesis, enzyme inhibitor therapy, kinase inhibitor therapy, gene therapy, biological therapy, and immune therapy.

 

As of March 2009 there were at least sixteen trials of these newer therapies plus eight combination regimes of a newer therapy and chemotherapy and another trial with radiation therapy.  These newer therapies include treatments designed to inhibit tumor cell surface receptors (like Dasatinib, Imatinib, Sorafenib), treatments that inhibit growth factor receptors (like Vandetanib and Bevacizumab), antibodies (like MORAb-009 and SS1(dsFv)-PE38 immunotoxin), and proteasome inhibitors (like Bortezomib).

Below is a list of some of the clinical trials being offered for mesothelioma.  You are urged to check the National Cancer Institute website for the most current list.  It is available here:http://www.cancer.gov/clinicaltrials/search

Newer Therapies

Vorinostat (MK0683, SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma

Phase II Study of AZD2171 in Patients With Malignant Pleural, Peritoneal, or Tunica Vaginalis Mesothelioma That is Not Amenable to Curative Surgery

Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma

Phase II Study of Sunitinib Malate in Patients With Advanced Malignant Pleural Mesothelioma

Phase II Study of Dasatinib in Patients With Previously Treated Malignant Mesothelioma

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage IV Mesothelioma

Phase II Study of Bortezomib in Patients With Malignant Pleural Mesothelioma

An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma

An Efficacy Study of MORAb-009 in Subjects With Pleural Mesothelioma

Phase II Study of Everolimus in Patients With Unresectable Malignant Pleural Mesothelioma

Sorafenib in Previously Treated Malignant Mesothelioma

Dasatinib in Resectable Malignant Pleural Mesothelioma

Pharmacokinetic, Safety, and Efficacy Effects of Oral LBH589 on Dextromethorphan in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer or Malignant Pleural Mesothelioma

Phase I Study of FR901228 (Depsipeptide) and Flavopiridol in Patients With Advanced Primary Lung or Esophageal Cancer, Malignant Pleural Mesothelioma, or Lung or Pleural Metastases

Newer  Therapy + Chemotherapy

Study of CBP501 + Pemetrexed + Cisplatin in Patients With Solid Tumors (Phase I) and Patients With Malignant Pleural Mesothelioma (Phase II)

Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma

Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma

Phase II Study of Bortezomib and Cisplatin as First-Line Treatment in Patients With Malignant Mesothelioma

A Phase II Study of the Association of Glivec® Plus Gemzar® in Patients With Unresectable, Refractory, Malignant Mesothelioma

Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma

Oxaliplatin and Paclitaxel Plus Bevacizumab in Advanced Peritoneal Carcinomatosis

Phase I Study of SS1(dsFv)-PE38 Immunotoxin in Combination With Pemetrexed Disodium and Cisplatin in Patients With Unresectable Malignant Epithelial Pleural Mesothelioma

Chemotherapy

Mesothelioma Avastin Plus Pemetrexed-Cisplatin Study

Carboplatin, Bevacizumab and Pemetrexed in the First-Line Treatment of Patients With MPM

Phase II Study of Pemetrexed Disodium, Cisplatin, and Vitamin B12 in Patients With Unresectable Pleural Mesothelioma

Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma

Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

Phase I Study of Gene Induction Mediated by Sequential Decitabine/Depsipeptide Infusion in Subjects with Pulmonary and Pleural Malignancies

Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomid

Surgery

Phase III Randomized Study of Video-Assisted Thoracoscopic Cytoreductive Pleurectomy Versus Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma

Surgery + Chemotherapy

Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate

Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis

Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma

Radiation

Short Neoadjuvant Hemithoracic IMRT for MPM

Tomotherapy Treatment for Mesothelioma

Chemotherapy + Radiation

Study Using Chemotherapy Followed by Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced But Unresectable Malignant Pleural Mesothelioma

Newer Therapy + Radiation

Phase I Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

Surgery + Chemotherapy + Radiation

Phase II Randomized Study of Neoadjuvant Therapy With Pemetrexed Disodium and Cisplatin Followed By Extrapleural Pneumonectomy With or Without Postoperative Hemithoracic Radiotherapy in Patients With Malignant Pleural Mesothelioma

Randomized Pilot Study of Neoadjuvant Combination Chemotherapy With Versus Without Surgery and Adjuvant Radiotherapy in Patients With Resectable Malignant Mesothelioma

Gene Therapy

Gene Therapy for Pleural Malignancies

Immune Therapy

Dendritic Cell-Based Immunotherapy in Mesothelioma

http://www.survivingmesothelioma.com/news/view.asp?ID=0026

 
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Chemoradiotherapy for Hodgkin Lymphoma Raises Mesothelioma Risk

March 10, 2009 • Volume 6 / Number 5

The primary risk factor for malignant mesothelioma is exposure to asbestos. However, new results published online February 20 inBlood add to the evidence that radiotherapy, especially to the chest, also increases the risk. This study of long-term Hodgkin lymphoma (HL) survivors found that the risk was greatest in radiation patients who had also received chemotherapy.

A group of 2,567 patients treated for HL in theNetherlands between 1965 and 1995 were followed for a median of 18.1 years. While only eight men and five women developed mesothelioma, this rate was 25.7 times that found in the general population. Risk in women was dramatically greater (85 times the general population rate) than in men (18 times the general population rate).

The researchers also analyzed the risk according to the type of treatment the patients originally received for HL. Mesothelioma developed in only 1 of the 730 who received radiation alone (a 5.8 fold increase over the general population), and in none of the 232 patients who received chemotherapy alone. The remaining 12 patients received both treatments, and their chances of getting the disease were 44.8 times that of the general population. In all cases but one, the mesothelioma tumors developed in the field that had been irradiated during HL treatment.

Only seven of the patients had a documented history of asbestos exposure. Historically in theNetherlands, only about one in seven malignant mesothelioma patients have no history of exposure. Thus, said Dr. Marie L. De Bruin of the Netherlands Cancer Institute, “the diagnosis mesothelioma should be kept in mind whenever new symptoms arise in patients who had previous irradiation.”

http://www.cancer.gov/ncicancerbulletin/031009/page3

 
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Finding Clinical Trials for Mesothelioma

MesotheliomaWeb.org Offers Listings for Current Clinical Trials

Houston,TX 2/11/2009 08:37 PM GMT (TransWorldNews)

 

For mesothelioma patients who are interested in getting into a clinical trial for a new treatment, but don't have an strong understanding of how it all works, MesotheliomaWeb.org has a “Clinical Trials” section.  The site also links to ongoing clinical trials that accept mesothelioma patients.

The section explains the basics of clinical trials – what they are and the purpose behind them.  Those interested in participating in a trial are advised to first consult with their doctors to decide whether it is right for them.

There are benefits and risks associated with any clinical trial, and it is good for patients to be aware of what they are.  Benefits may include receiving care at highly regarded facilities from expert cancer physicians and having access to a new a drug not yet available to the public.  One risk is that travel may be required to the location of the trial so people who are not fit to travel should not do so.  Another is that the drug from the clinical trial may not treat the disease as well as the “standard” forms of treatment.

Not all studies are the same and eligibility guidelines for participants vary by trial.  Some accept patients who have already received other forms of treatment while other clinical trials only accept those who have never received treatment.

Some clinical trials compare a new drug to the drug that is currently considered the “standard”.  The patient will not be told which one they get until the trial is over.  Unlike some other types of studies, these generally do not involve any placebo pills.

Clinical trials are divided into three phases.  Phase I trials involves testing how new treatments should be administered.  Phase II trials give early information about whether the new treatment is effective and discusses the safety and benefits of the treatment.  In Phase III, some patients are given the new treatment while others are given the standard treatment, and the effectiveness of each are compared.

Patients with Medicare should be aware of what costs will and will not be covered.  Clinical trials are only covered if the trial is funded by the National Cancer Institute (NCI), theNCI-DesignatedCancerCenters, the NCI-Sponsored Clinical Trials Cooperative Groups or other Federal agencies that fund cancer research.  Trials that have goals of diagnosing or treating cancer are covered, but those aimed at prevention of cancer are not.

MesotheliomaWeb.org also has a glossary and a Q&A  section for clinical trials and a regularly updated section that shows what clinical trials currently going on.

For more information, you can request a free informational packet from its website.  To speak with a Mesothelioma Web coordinator directly, call 1-877-367-6376.

About Mesothelioma Web: MesotheliomaWeb.org is a website dedicated to helping those diagnosed with mesothelioma.  It has an expert team that researches new treatment programs and news articles and maintains contact with doctors who specialize in treating the disease.

http://www.transworldnews.com/NewsStory.aspx?id=76099&cat=10

 
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Screening for Mesothelioma and Serum Osteopontin Level Testing

Diagnosis of malignant mesothelioma is often made too late to successfully remove the cancer or halt its progression. Consequently, researchers have been looking for a biomarker that would be definitive in diagnosing metastatic mesothelioma, but, as yet, have not been entirely successful. Serum osteopontin is a molecule whose presence is associated with metastatic mesothelioma. It one of three biomarkers that have raised a lot of interest, and generated many research studies around the world.

One study published in 2007 by the Pulmonary and Thoracic Oncology Department, Hopital Calmette (this is not a misspelling,) Lille, France concludes that osteopontin is not sufficiently specific to diagnose mesothelioma. They did conclude, however, that it might be useful in monitoring the disease. The paper states that cytohistology is still the most accurate diagnostic measure for mesothelioma. A study published by the Department of Surgery, Wayne State University, Karmanos Cancer Institute, John A. Dingell Veterans Hospital, Detroit, MI noted that the serum osteopontin levels measured notably higher in pleural mesothelioma patients, as compared to a group whose participants had been exposed to asbestos and had various asbestos-related diseases (plaques, fibrosis or both, but not mesothelioma.) Their conclusion was that serum osteopontin levels are useful for distinguishing between patients who have pleural mesothelioma and those that have other asbestos related diseases that are not cancerous.

A study by doctors at Institut National de la Sante et de la Recherche Medicale (INSERM) U774, Institut Pasteur de Lille,Lille,France studied both the diagnostic and prognostic value of osteopontin with slightly different results than other studies revealed. They concluded that osteopontin is less accurate as a diagnostic measure, but may have potential as a prognostic marker.

In a fourth study by doctors at the National Research Centre for Asbestos Related Diseases, Western Australian Institute of Medical Research, Nedlands, Australia similar results show that osteopontin is not the marker scientists hope to find. This report added that osteopontin levels did not differentiate between mesothelioma and other malignancies.

Most other studies seem to confirm these results, and each points to two other biomarkers as having the potential to provide differential diagnosis reliability. Of the three, soluble mesothelin-related peptide (SMRP) shows the most promise for both early detection of malignant mesothelioma and differentiating between benign and metastatic carcinomas.

Treatment for mesothelioma can be expensive, and impose great demands on you and your family. If you have been diagnosed with an asbestos-related disease, you may be entitled to a settlement to pay these expenses. Please contact the lawyers experienced in mesothelioma claims inBaltimore,Maryland andWashington,D.C.

http://www.bestsyndication.com/?q=node/22031

 
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About theAsbestos DiseaseAwareness Organization (ADAO)
Asbestos DiseaseAwareness Organization, ADAO, Linda Reinstein, BanAsbestos, www.adao.us

 

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mesothelioma
Mesothelioma is an incurableasbestos cancer. This short film was produced to raiseawareness of the issues around mesothelioma. It...

 

 

3:08
Dr. Irving Selikoff PioneeringAsbestos Disease Researcher
Dr. Irving J. Selikoff was a remarkable physician and scientist who contributed to knowledge in several areas of medicine, includingasbestos...

 

 
 
 
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