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

Alternate Title

Phase I Study of Vaccine Therapy Comprising Vaccinia-PSA-TRICOM Vaccine and Fowlpox-PSA-TRICOM Vaccine in Combination With Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody Ipilimumab (MDX-010) and Sargramostim (GM-CSF) in Patients With Androgen-Independent Metastatic Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	NCI-05-C-0167 7207, NCI-7207, NCT00124670

Trial Description

Purpose:

Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as MDX-010 and GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with MDX-010 and GM-CSF may be an effective treatment for prostate cancer.

This phase I trial is studying the side effects and best dose of MDX-010 when given together with vaccine therapy and GM-CSF in treating patients with metastatic prostate cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No brain metastases
• No previous MDX-010
• No previous chemotherapy
• No previous surgery to remove the spleen
• 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 a vaccine once in week 1. They will then receive an injection of a second vaccine and a 1½-hour infusion of MDX-010 once in weeks 3, 7, 11, 15, 19, and 23. Patients will also receive an injection of GM-CSF once a day for 4 days in weeks 1, 3, 7, 11, 15, 19, and 23. Some patients may continue to receive the second vaccine and GM-CSF every 4 weeks for as long as benefit is shown.

Patients will be evaluated at 4 weeks and once a year for 15 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

NCI - Center for Cancer Research

James Gulley, MD, PhD, FACP, Principal investigator		Ph: 301-435-2956 Email: gulleyj@mail.nih.gov

Related Information

Web site for additional information

Registry Information
Official Title		Phase I Trial of a PSA Based Vaccine and an Anti-CTLA-4 Antibody in Adults with Metastatic Androgen Independent Prostate Cancer
Trial Start Date		2005-06-06
Trial Completion Date		2007-02-26 (estimated)
Registered in ClinicalTrials.gov		NCT00124670
Date Submitted to PDQ		2005-06-15
Information Last Verified		2008-04-06

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