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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 Pilot Study of Adjuvant Irinotecan and Radiotherapy Followed By Irinotecan and Carmustine in Patients With Glioblastoma Multiforme (Phase I closed to accrual as of 3/5/2005)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	18 and over	NCI	NCCTG-N997D N997D, NCT00027612

Trial Description

Purpose:

Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Irinotecan may make the tumor cells more sensitive to radiation therapy.

This phase I/II trial is studying the side effects of irinotecan given together with radiation therapy followed by irinotecan and carmustine and to see how well it works in treating patients with newly- diagnosed glioblastoma multiforme.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No more than 8 weeks since surgery
• No previous chemotherapy or 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 receive a 1.5-hour infusion of irinotecan in weeks 1, 2, 4, and 5. They will also undergo radiation therapy 5 days a week for 6 weeks during course one only. Beginning with course two, patients will receive a 2-hour infusion of carmustine every 6 weeks and an infusion of irinotecan in weeks 1, 2, 4, and 5. Treatment may be repeated every 6 weeks for up to five courses. Patients will be evaluated every 3-6 months for 5 years and once a year for 5-10 years.

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 Central Cancer Treatment Group

Kurt Jaeckle, MD, Protocol chair		Ph: 904-953-7102

Registry Information
Official Title		Pilot And Phase II Trial Of Irinotecan And Radiation Followed By Irinotecan And BCNU In Glioblastoma Multiforme Patients
Trial Start Date		2002-07-26
Trial Completion Date		2009-07-10
Registered in ClinicalTrials.gov		NCT00027612
Date Submitted to PDQ		2001-10-05
Information Last Verified		2009-07-10
NCI Grant/Contract Number		CA25224

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