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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 Mutant MGMT Gene Transfer into Human Hematopoietic Progenitors to Protect Hematopoiesis During O6-Benzylguanine and Carmustine Followed by O6-Benzylguanine and Temzolomide in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 to 70	NCI	CASE-CWRU-2Y97 NCI-T97-0060, NCT00003567, T97-0060, CASE-2Y97

Trial Description

Purpose:

Gene therapy may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

This phase I trial is studying the side effects and best dose of gene therapy together with chemotherapy in treating patients with advanced solid tumors or non-Hodgkin's lymphoma.

Eligibility:

Eligibility criteria include the following:

• 18-70 years old
• Evaluable or measurable disease
• No bone marrow involvement
• At least 4 weeks since myelosuppressive therapy
• No previous stem cell transplantation
• No previous carmustine
• 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 injections of sargramostim and filgrastim for 5 days. Peripheral stem cells will be collected on days 5 and 6 and treated in the laboratory. Patients will receive infusions of O(6)-benzylguanine and carmustine every 6 weeks for five courses. Three days after completing the first course of chemotherapy, the treated stem cells will be reinfused. Four weeks after stem cell reinfusion, patients will receive infusions of O6-benzylguanine and temozolomide every 4 weeks for approximately 5 courses.

Patients will be followed once a month for 2 months, every 4 months for 8 months, and every 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

Case Comprehensive Cancer Center

Stanton Gerson, MD, Protocol chair		Ph: 216-844-8562

Registry Information
Official Title		Mutant MGMT Gene Transfer into Human Hematopoietic Progenitors to Protect Hematopoiesis During O6-Benzylguanine (BG, NSC 637037) and Carmustine Followed by Temozolomide Therapy of Advanced Solid Tumors
Trial Start Date		1999-05-14
Trial Completion Date		2007-01-11
Registered in ClinicalTrials.gov		NCT00003567
Date Submitted to PDQ		1998-09-02
Information Last Verified		2007-03-01
NCI Grant/Contract Number		CA43703, CA76192

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