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Vorinostat in Treating Patients With Progressive or Relapsed Advanced Malignant Mesothelioma
February 13, 2006

Alternative Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information

Alternative Title

Phase III Randomized Study of Vorinostat (SAHA) in Patients With Progressive or Relapsed Advanced Malignant Pleural Mesothelioma

Basic Trial Information

Trial Description

Purpose:

Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether vorinostat is more effective than a placebo in treating malignant mesothelioma.

This randomized phase III trial is studying vorinostat to see how well it works compared to placebo in treating patients with progressive or relapsed advanced malignant mesothelioma.

Eligibility:

Eligibility criteria include the following:

    · At least 18 years old
    · Cancer did not respond to or came back after one or two previous treatment regimens that included pemetrexed and cisplatin or carboplatin
    · At least 4 weeks since chemotherapy or radiation therapy

Final eligibility for a clinical trial is determined by the health professionals conducting the trial. For more details about the eligibility requirements for this trial and the treatment or intervention, refer to the Health Professional version of the trial summary.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive vorinostat by mouth twice a day 3 days a week. Treatment may continue for as long as benefit is shown.

Patients in group two will receive a placebo by mouth twice a day 3 days a week. Treatment may continue for as long as benefit is shown.

Quality of life will be assessed before beginning treatment, every 3 weeks for up to 6 months during treatment, within 1 month after finishing treatment, and every 2 months thereafter. After finishing treatment, patients will be evaluated within 1 month and every 2 months thereafter.

Important:

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations:

NCI - Center for Cancer Research

Raffit Hassan, MD, Protocol chair
     Ph: 301-451-8742

Trial Sites and Contacts:

U.S.A.

Maryland

    Bethesda

    Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    NCI Clinical Studies Support
    Ph: 888-NCI-1937

***Source: http://www.cancer.gov/clinicaltrials***