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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020228 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Vaccine therapy may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate the white blood cells to kill tumor cells.
PURPOSE: This randomized phase II trial is studying radiation therapy, vaccine therapy, and interleukin-2 to see how well they work compared to radiation therapy alone in treating patients with prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: aldesleukin Drug: recombinant fowlpox-prostate apecific antigen vaccine Drug: recombinant vaccinia prostate-specific antigen vaccine Drug: recombinant vaccinia-B7.1 vaccine Drug: sargramostim Procedure: brachytherapy Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase II Study of a PSA-Based Vaccine in Patients With Localized Prostate Cancer Receiving Standard Radiotherapy |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to planned radiotherapy (irradiation alone vs irradiation and radioactive implant) and planned hormonal therapy (yes vs no). Patients are randomized to treatment arms I or II and, once accrual on these arms is complete, up to 20 patients (9-10 HLA-A2 positive) are accrued to arm III.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 13 years.
PROJECTED ACCRUAL: A total of 48-49 patients (19 for arm I, 11 for arm II, and 18-19 for arm III) will be accrued for this study within 10-15 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Immunologic:
No autoimmune disease, including any of the following:
Other:
No close household contact with the following individuals for at least two weeks after vaccinia inoculation:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
NCI - Center for Cancer Research | |
Bethesda, Maryland, United States, 20892 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | James Gulley, MD, PhD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000068093, NCI-00-C-0154, NCI-NMOB-B00-021, NCI-894 |
Study First Received: | July 11, 2001 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00020228 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer |
Aldesleukin Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Anti-Infective Agents Neoplasms Anti-HIV Agents Neoplasms by Site Anti-Retroviral Agents |
Antineoplastic Agents Therapeutic Uses Antiviral Agents Pharmacologic Actions |