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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Temozolomide Versus Procarbazine, Lomustine, and Vincristine in Patients With Recurrent Malignant Glioma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over Other MRC-BR12 EU-20114, ISRCTN83176944, NCT00052455

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating recurrent malignant glioma.

Randomized phase III trial to compare the effectiveness of temozolomide alone to that of procarbazine, lomustine, and vincristine in treating patients who have recurrent malignant glioma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Evaluable disease
• No previous chemotherapy, radiosurgery, or brachytherapy for this disease
• At least 2 months since radiation therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups.

Patients in group one will receive temozolomide by mouth once a day for either 5 days or 3 weeks. Treatment may be repeated every 4 weeks for up to nine courses.

Patients in group two will receive lomustine by mouth and an infusion of vincristine on day 1. They will also receive procarbazine by mouth once a day for 3 weeks. Treatment may be repeated every 6 weeks for up to six courses.

Quality of life will be assessed periodically in both groups. Patients will be evaluated every 3 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

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

Institute of Cancer Research - London

Simon Clawson, Protocol chair		Ph: 44-207-670-4801

United Kingdom
England
	London
	Medical Research Council Clinical Trials Unit
		Simon Clawson	Ph:  44-207-670-4801

Registry Information
Official Title		A Prospective Randomised Trial Comparing Temozolomide With PCV In The Treatment Of Recurrent WHO Astrocytic Tumours Grades III And IV
Trial Start Date		2002-10-01
Registered in ClinicalTrials.gov		NCT00052455
Date Submitted to PDQ		2002-09-30
Information Last Verified		2007-05-23