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ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
August 25, 2005

Basic Trial Information
Trial Description
Eligibility
Treatment/Intervention
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Active 21 and over Pharmaceutical / Industry ALFACELL-P30-302NCT00003034, NCI-V97-1273

Trial Description
Purpose:

Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether Onconase plus doxorubicin is more effective than doxorubicin alone in treating patients with malignant mesothelioma.

This randomized phase III trial is studying doxorubicin alone to see how well it works compared to doxorubicin and Onconase in treating patients with malignant mesothelioma.

Eligibility:

Eligibility criteria include the following:

    · At least 21 years old
    · Measurable or evaluable disease
    · No CNS metastases
    · No previous doxorubicin
    · At least 6 weeks since chemotherapy

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 to one of two groups. Patients in group one will receive an infusion of Onconase and an infusion of doxorubicin once a week for at least 18 weeks. They may then receive Onconase alone for as long as benefit is shown. Patients in group two will receive an infusion of doxorubicin alone once a week for up to 18 weeks. Quality of life will be assessed.

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. 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 (http://www.cancer.gov/clinicaltrials).

Trial Contact Information

Trial Lead Organizations:

Alfacell Corporation

Diane Scudiery, Protocol chair
Ph: 973-748-8082

Trial Sites and Contacts:

U.S.A.

New Jersey

    Somerville

    Somerset Medical Center
    Hen-Vai Wu, MD
    Ph: 908-685-2481

New York

    Brooklyn

    SUNY Downstate Medical Center
    William Solomon, MD
    Ph: 718-270-2931
    Email: wsolomon@downstate.edu

    New York

    Mount Sinai School of Medicine
    Stuart Packer, MD
    Ph: 212-241-8617
    Email: stuart.packer@mssm.edu

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




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Mesothelioma Information Resource Group, MIRG.org, tries to assist individuals and families in learning about mesothelioma and other asbestos related injuries. It is the aim of MIRG.org to provide an account of the disease mesothelioma, its causes, various treatment options and potential legal impact. To find out more about Mesothelioma and other asbestos related diseases, new medical advances, and clinical trials now available please use the links provided.
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