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

Alternate Title

Phase I Pilot Study of Cranial Radiotherapy With Radiosensitization Comprising Pentoxifylline and Hydroxyurea in Patients With Glioblastoma Multiforme (Summary Last Modified 12/2001)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	Over 18	NCI	NCI-95-C-0069 NCI-95-C-0069A, NCI-95-C-0069D, NCT00019058

Trial Description

Purpose:

Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as pentoxifylline and hydroxyurea may make tumor cells more sensitive to radiation therapy.

Phase I trial to study the effectiveness of radiation therapy plus pentoxifylline and hydroxyurea in treating patients who have high-grade astrocytoma or glioblastoma.

Eligibility:

• At least 19 years old
• No previous radiation therapy or chemotherapy
• At least 7 days but no more than 3 months since surgery or biopsy
• 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 radiation therapy twice a day 5 days a week for 4 weeks. Patients will also receive a 5-day continuous infusion of hydroxyurea and pentoxifylline during each week of radiation therapy. Patients will be evaluated at 1 week, 1 month, 3 months, every 3 months for 2 years, and then every 4 months for 5 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

NCI - Center for Cancer Research

Brian G. Fuller, MD, Protocol chair		Ph: 301-496-5457 Email: bgfuller@box-b.nih.gov

Registry Information
Official Title		A PHASE I STUDY OF COMBINED RADIATION RESPONSE MODIFIERS EMPLOYING HYDROXYUREA AND PENTOXIFYLLINE FOR TREATMENT OF GLIOBLASTOMA
Trial Start Date		1995-04-01
Registered in ClinicalTrials.gov		NCT00019058
Date Submitted to PDQ		1995-04-01
Information Last Verified		2001-12-01

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