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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 Intratumor BG00001 (Adenoviral Vector Encoding Human Interferon beta) in Patients With Recurrent or Progressive Glioblastoma Multiforme

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	Pharmaceutical / Industry	BIOGEN-C-1502 UARIZ-HSC-01197, NCI-V02-1696, NCT00036725

Trial Description

Purpose:

Inserting the gene for interferon-beta into a person's glioblastoma cells may make the body build an immune response to kill tumor cells.

Phase I trial to study the effectiveness of gene therapy in treating patients who have recurrent or progressive glioblastoma multiforme.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No previous gene therapy
• At least 4 weeks since chemotherapy
• At least 8 weeks since 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 an injection of the gene directly into the tumor. One week later they will undergo surgery to remove the tumor and receive a second injection of gene therapy into the tissue surrounding the tumor. Patients will be evaluated periodically for 1 year 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

Biogen Idec, Incorporated

Steven Rosenfeld, MD, PhD, Protocol chair		Ph: 205-934-1432 Email: s_rosenfeld@mail.neruo.uab.edu

Registry Information
Official Title		A Muliti-Center, Open Label, Two Part, Dose Escalation Study To Determine The Tolerability Of Interferon-Beta Gene Transfer (BG00001) In The Treatment Of Recurrent Or Progressive Glioblastoma Multiforme
Trial Start Date		2002-01-01
Registered in ClinicalTrials.gov		NCT00036725
Date Submitted to PDQ		2002-02-27
Information Last Verified		2006-09-25

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