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Mesothelioma Articles
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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