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

Alternate Title

Phase I/II Study of Irinotecan and Temozolomide in Patients With Recurrent Malignant Glioma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	18 and over	NCI	NABTC-9907 UCLA-0006095, NCT00006025

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.

Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma.

Eligibility:

• At least 18 years old
• Measurable disease
• At least 4 weeks since chemotherapy or radiation therapy
• No previous temozolomide or irinotecan
• At least 1 week since surgery
• 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 receive temozolomide by mouth once a day on days 1-5 and an infusion of irinotecan on days 1 and 14. Treatment may be repeated every 4 weeks for up to 1 year. Patients will receive follow-up evaluations every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, and every 4-6 months thereafter.

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

North American Brain Tumor Consortium

Wai-Kwan Yung, MD, Protocol chair		Ph: 713-794-1285; 800-392-1611

Registry Information
Official Title		Phase I-II Trial of CPT-11 and Temozolomide (Temodar) in Patients with Recurrent Malignant Glioma
Trial Start Date		2000-11-14
Trial Completion Date		2008-05-07
Registered in ClinicalTrials.gov		NCT00006025
Date Submitted to PDQ		2000-05-30
Information Last Verified		2004-08-27
NCI Grant/Contract Number		CA62399

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