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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 Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Patients With Glioblastoma Multiforme or Intracranial Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	NCI	BIDMC-E-010284FB NEDH-E-010284FB, NCI-V02-1702, NCT00039572

Trial Description

Purpose:

Radiation therapy such as boron neutron capture therapy may kill tumor cells without harming normal tissue.

Phase I/II trial to study the effectiveness of boron neutron capture therapy in treating patients who have glioblastoma multiforme or melanoma metastatic to the brain.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No previous radiation therapy to the brain
• 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 a 90-minute infusion of a drug containing the element boron followed by neutron radiation therapy to the brain on days 1 and 2. Patients will be evaluated once a month for 2 months, every 2 months for 4 months, every 3 months for 6 months, and every 6 months for 2 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

Beth Israel Deaconess Medical Center

Paul Busse, MD, PhD, Protocol chair		Ph: 617-667-2345

Registry Information
Official Title		A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma
Trial Start Date		2002-05-13
Registered in ClinicalTrials.gov		NCT00039572
Date Submitted to PDQ		2002-04-30
Information Last Verified		2002-07-31
NCI Grant/Contract Number		R21-CA94617

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