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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 Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody (MDX-CTLA4) in Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndromes, or Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	Over 18	NCI	DFCI-NCI-5708 NCI-5708, NCT00039091, 5708

Trial Description

Purpose:

Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

This phase I trial is studying the side effects of monoclonal antibody therapy in treating patients with ovarian epithelial cancer, melanoma, acute myeloid leukemia, myelodysplastic syndrome, or non-small cell lung cancer.

Eligibility:

Eligibility criteria include the following:

• At least 19 years old
• Measurable disease
• At least 4 weeks since biological therapy, chemotherapy, hormone therapy, radiation therapy, or surgery
• 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 monoclonal antibody every 2 months for as long as benefit is shown. Patients will be evaluated once a month.

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

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

F. Stephen Hodi, MD, Protocol chair		Ph: 617-632-5053; 866-790-4500

Registry Information
Official Title		Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 (Anti-CTLA-4) Humanized Monoclonal Antibody (MDX-CTLA-4 NSC # 732442 [previously # 720801]) in Patients Previously Vaccinated with GM CSF-Based Autologous Tumor Vaccines (CTEP Protocol Number P-5708) and Patients with Acute Myelogenous Leukemia/Myelodysplasia, and Non-Small Cell Lung Cancer Who Have Not Received Prior Vaccine
Trial Start Date		2002-03-22
Trial Completion Date		2003-07-15 (estimated)
Registered in ClinicalTrials.gov		NCT00039091
Date Submitted to PDQ		2002-03-29
Information Last Verified		2007-10-05
NCI Grant/Contract Number		CA06516

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