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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 Hydroxychloroquine, Radiotherapy, and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI	ABTC-0603 NABTT-0603, 0603, NCT00486603

Trial Description

Purpose:

Drugs used in chemotherapy, such as hydroxychloroquine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving hydroxychloroquine together with temozolomide and radiation therapy may kill more tumor cells.

This phase I/II trial is studying the side effects and best dose of hydroxychloroquine when given together with radiation therapy and temozolomide and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No more than 3 months since diagnosis of brain tumor
• Has undergone surgery to remove the tumor or biopsy within the past 3 months
• No previous radiation therapy, chemotherapy, biological therapy, or hormone therapy for the brain tumor
• No previous Gliadel wafers or brachytherapy
• 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 for 6 weeks. They will also undergo radiation therapy 5 days a week for 6 weeks and receive hydroxychloroquine by mouth once a day for 10 weeks.

Beginning 4 weeks after finishing radiation therapy, patients will receive temozolomide by mouth for 5 days in week 1 and hydroxychloroquine by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for up to six courses. Patients may then continue to receive hydroxychloroquine alone for as long as benefit is shown.

Patients will undergo blood and tissue sample collection periodically for laboratory studies.

After finishing treatment, patients will be evaluated every 2 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

Adult Brain Tumor Consortium

Myrna Rosenfeld, MD, PhD, Protocol chair		Ph: 215-746-4707 Email: myrna@mail.med.upenn.edu

U.S.A.
Alabama
	Birmingham
	UAB Comprehensive Cancer Center
		Clinical Trials Office - UAB Comprehensive Cancer Center	Ph:  205-934-0309
Florida
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
		Clinical Trials Office - H. Lee Moffitt Cancer Center and Reseach Institute	Ph:  800-456-7121
			Email: canceranswers@moffitt.org
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Jeffrey Olson, MD	Ph:  404-778-5770 888-946-7447
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu
Massachusetts
	Boston
	Massachusetts General Hospital
		Clinical Trials Office - Massachusetts General Hospital	Ph:  877-726-5130
Michigan
	Detroit
	Josephine Ford Cancer Center at Henry Ford Hospital
		Tom Mikkelsen, MD	Ph:  313-916-8641 888-734-5322
			Email: nstom@neuro.hfh.edu
North Carolina
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
Ohio
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph:  800-641-2422
Pennsylvania
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania	Ph:  800-474-9892

Registry Information
Official Title		A Phase I/II Trial of Hydroxychloroquine in Conjunction with Radiation Therapy and Concurrent and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme
Trial Start Date		2007-10-11
Trial Completion Date		2009-06-24 (estimated)
Registered in ClinicalTrials.gov		NCT00486603
Date Submitted to PDQ		2007-05-08
Information Last Verified		2009-06-07
NCI Grant/Contract Number		CA62475

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