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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

This study is currently recruiting patients

Sponsored by

National Cancer Institute (NCI)

BASIC TRIAL INFORMATION

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

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.

Randomized phase III trial comparing Onconase plus doxorubicin with doxorubicin alone in treating patients with malignant mesothelioma.

Eligibility:

   •   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 at the National Cancer Institute (NCI)

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.

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: 908-685-2200

New York
New York
Herbert Irving Comprehensive Cancer Center at Columbia University
Robert Taub, MD, PhD
Ph: 212-305-4076


Source: National Cancer Institute


***Please note that the clinical trials listed on this page have additional specific requirements. Call contacts listed for each trial for more detailed information.



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