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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020254 |
Purpose
RATIONALE: Vaccines made from prostate cancer cells may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill prostate cancer cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using nilutamide may fight prostate cancer by reducing the production of androgens. It is not yet known which treatment regimen is more effective for treating prostate cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus sargramostim and interleukin-2 with that of nilutamide alone in treating patients who have prostate cancer that has not responded to hormone therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: aldesleukin Drug: nilutamide Drug: recombinant fowlpox-prostate apecific antigen vaccine Drug: recombinant vaccinia prostate-specific antigen vaccine Drug: recombinant vaccinia-B7.1 vaccine Drug: sargramostim |
Phase II |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to HLA-A2 typing (positive vs negative). Patients are randomized to one of two treatment arms.
Patients without disease progression after 12 courses receive the vaccine regimen every 12 weeks.
After 6 months of therapy, patients with a rising PSA and no radiographic evidence of disease progression may receive therapy in the other arm in addition to the therapy to which they were randomized.
Patients are followed monthly for 6 months and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 56-78 patients (28-39 per treatment arm) will be accrued for this study within 1.5-2 years.
Eligibility
DISEASE CHARACTERISTICS:
Histologically confirmed hormone-refractory adenocarcinoma of the prostate
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Immunologic:
No autoimmune disease, including the following:
Other:
No close or household contact for at least 2 weeks after each vaccinia virus inoculation with the following high-risk individuals:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Philip M. Arlen, MD | National Cancer Institute (NCI) |
More Information