Protocol Number: 00-C-0137

Title:

A Randomized Phase II Study of Either Immunotherapy w/a Regimen of Recombinant Pox Viruses that Express PSA/B7.1 + Adjuvant GM-CSF & IL-2 or Hormone Tx with Nilutamide in Patients w/Hormone Refractory Prostate Ca and No Radiographic Evidence of Disease

Number:

00-C-0137

Summary:

This study will compare the effectiveness of the drug nilutamide with that of an experimental vaccine in controlling advanced prostate cancer. Nilutamide (Nilandron) is an anti-androgen approved for treating prostate cancer. The vaccine is composed of the following parts: rV-PSA - vaccinia virus plus human DNA that produces PSA (prostate specific antigen); rV-B7.1 - vaccinia virus plus human DNA that produces B7.1 (a protein that helps guide immune cells to their targets); rF-PSA - fowlpox virus plus human DNA that produces PSA; and GM-CSF and IL-2 - drugs that boost the immune system.

Patients 18 years or older who have advanced prostate cancer that has not responded to hormonal therapy and who have been vaccinated against smallpox may be eligible for this study. Patients must have a rising PSA level but no X-ray evidence of tumor spread to other parts of the body. Candidates will be screened with X-rays, CT and MRI scans, skin tests similar to those for allergy or tuberculosis testing, and blood tests. Participants will be randomly assigned to one of the following treatment groups:

1. Vaccination - Patients in this group will receive the vaccine in 28-day treatment cycles, delivered in five parts during each cycle, as follows: GM-CSF on days 1 through 4; IL-2 days 8 through 12; rV-PSA and rV-B7.1 day 2; and rF-PSA days 30, 58, 86, etc. (i.e., every 4 weeks, beginning 4 weeks after the first rV-PSA and rV-B7.1 injection). The vaccinations are injected under the skin of the upper arm. Treatment will continue as long as the cancer is controlled and there are no serious side effects. Patients will have 15 cc (one tablespoon) of blood drawn once a week for the first month and then 60 cc (4 tablespoons) once every 4 weeks. Scans and X-rays will be done after 3 months, 6 months, and then every 2 months. Patients who, after 6 months, have a rising PSA level but no X-ray evidence of disease progression will be offered the option of switching to nilutamide therapy.

2. Nilutamide - Patients in this group will take the hormone by mouth, 6 tablets per day for the first month and 3 tablets per day thereafter. Treatment will continue as long as the cancer is controlled and there are no serious side effects. Patients will have 15 cc (one tablespoon) of blood drawn once a week for the first month and then 60 cc (4 tablespoons) once every 4 weeks. Patients who, after 6 months, have a rising PSA level but no X-ray evidence of disease progression will be offered the option of switching to vaccine therapy.

All patients will have HLA tissue typing at the beginning of the study. Those who are type HLA-A2 will be asked to undergo the following additional procedures, which enable studies of the immune response that can be done only with this tissue type.

- Lymphapheresis - A procedure similar to donating whole blood, but requiring 2 to 3 hours. In lymphapheresis, the blood is separated into its components by a machine, the lymphocytes (a type of white blood cell) are removed, and the rest of the blood is returned to the body.

- Blood collection (60 cc) every 4 weeks

- Prostate biopsy - Removal of a small sample of tumor tissue, done under local anesthetic.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male

Referral Letter Required: No

Population Exclusion(s): Female

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions: Currently Not Provided

Disease Category:

PROTICD

Keywords:

Cytotoxic T Lymphocytes

Elispot Assay

Recruitment Keywords:

Prostate Cancer

Hormone Refractory Prostate Cancer

Conditions:

Prostate Cancer

Prostate Neoplasm

Investigational Drug(s):

rV-PSA

rF-PSA

rV-B7.1

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Tumor rejection after direct costimulation of CD8+ T cells by B7-transfected melanoma cells

Costimulation of antitumor immunity by the B7 counterreceptor for the T lymphocyte molecules CD28 and CTLA-4

Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone resistant prostate cancer: a canadian randomized trial with palliative end points

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/23/2004