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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/II Randomized Pilot Study of Sequential Vaccination With Vaccinia-PSA-TRICOM Vaccine and Fowlpox-PSA-TRICOM Vaccine With or Without Sargramostim (GM-CSF) or Fowlpox-GM-CSF in Patients With Metastatic Prostate Cancer (Phase I closed to accrual as of 6/2/04.)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	NCI	NCI-03-C-0176 03-C-0176, NCI-5911, 5911, NCT00062153

Trial Description

Purpose:

Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells.

This phase I/II trial is studying five different vaccine therapy regimens with or without sargramostim and comparing them to see how well they work in treating patients with metastatic prostate cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No brain metastases
• At least 4 weeks since radiation therapy
• 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 be assigned to one of five groups.

• Patients in group one will receive an injection of one vaccine in weeks 1, 5, and 9.
• Patients in group two will receive an injection of one vaccine in week 1 and an injection of a second vaccine in weeks 5 and 9.
• Patients in group three will receive injections of two vaccines as in group two, and an injection of sargramostim 4 days a week in weeks 1, 5, and 9.
• Patients in group four will receive injections of two vaccines as in group two, and an injection of modified sargramostim in weeks 1, 5, and 9.
• Patients in group five will receive injections of two vaccines as in group two, and high-dose modified sargramostim as in group four.

Patients may then receive vaccinations once a month for 12 weeks and then every 12 weeks for as long as benefit is shown.

Patients will be evaluated 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

Featured trial article

Registry Information
Official Title		A Phase I/II Pilot Study Of Sequential Vaccinations With rFowlpox-PSA (L155)-Tricom (PROSTVAC-F/TRICOM) Alone, Or In Combination With rVaccinia-PSA(L155)-TRICOM (PROSTVAC-V/TRICOM), And The Role Of GM-CSF, In Men With Prostate Cancer
Trial Start Date		2003-05-12
Trial Completion Date		2006-02-28 (estimated)
Registered in ClinicalTrials.gov		NCT00062153
Date Submitted to PDQ		2003-04-28
Information Last Verified		2007-01-10

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