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

Alternate Title

Phase II Study of Intrathecal Iodine I 131 Monoclonal Antibody 3F8 in Patients With GD2-Expressing Central Nervous System or Leptomeningeal Neoplasms

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Biomarker/Laboratory analysis, Treatment Active Any age Other MSKCC-05122 NCT00445965

Trial Description

Purpose:

Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8, can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for central nervous system cancer or leptomeningeal cancer.

This phase II trial is studying the side effects and how well iodine I 131 monoclonal antibody 3F8 works in treating patients with central nervous system cancer or leptomeningeal cancer.

Eligibility:

Eligibility criteria include the following:

• Any age
• More than 3 weeks since radiation therapy to the brain or spine
• More than 3 weeks since chemotherapy (other than corticosteroids)
• 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 intrathecal iodine I 131 monoclonal antibody 3F8 on day 1. Treatment may repeat every 2 weeks for up to four courses.

Patients will undergo blood and cerebrospinal fluid sample collection before and after treatment for laboratory studies.

After finishing treatment, patients will be evaluated periodically for 3 months.

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

Memorial Sloan-Kettering Cancer Center

Kim Kramer, MD, Protocol chair		Ph: 212-639-6410; 800-525-2225 Email: kramerk@mskcc.org

U.S.A.
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Kim Kramer, MD	Ph:  212-639-6410 800-525-2225
			Email: kramerk@mskcc.org

Registry Information
Official Title		Phase II Study of Intrathecal 131I-3F8 in Patients with GD2-Expressing Central Nervous System and Leptomeningeal Neoplasms
Trial Start Date		2006-01-20
Trial Completion Date		2010-01-20 (estimated)
Registered in ClinicalTrials.gov		NCT00445965
Date Submitted to PDQ		2007-02-06
Information Last Verified		2008-12-14
NCI Grant/Contract Number		CA08748