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

Alternate Title

Phase I Study of Temozolomide in Pediatric Patients With Refractory or Recurrent Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	1 to 21	NCI	COG-ADVL0411 ADVL0411, NCT00083070

Trial Description

Purpose:

Drugs used in chemotherapy, such as temozolomide, work in different ways to stop cancer cells from dividing so they stop growing or die.

This phase I trial is studying the side effects and best dose of temozolomide in treating young patients with refractory or recurrent leukemia.

Eligibility:

Eligibility criteria include the following:

• 1-21 years old
• At least 1 week since biological therapy
• At least 3 months since stem cell transplantation
• 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 5 days. Treatment may be repeated every 4 weeks for up to 12 courses.

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

Children's Oncology Group

Terzah Horton, MD, PhD, Protocol chair		Ph: 832-824-4269 Email: tmhorton@txccc.org

Registry Information
Official Title		A Phase I Trial Of Temozolomide In Pediatric Patients With Refractory/Recurrent Leukemias
Trial Start Date		2004-03-22
Registered in ClinicalTrials.gov		NCT00083070
Date Submitted to PDQ		2004-03-17
Information Last Verified		2006-03-08
NCI Grant/Contract Number		CA97452

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