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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020254 |
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 |
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Prostate Cancer |
Biological: aldesleukin Biological: recombinant fowlpox-prostate apecific antigen vaccine Biological: recombinant vaccinia prostate-specific antigen vaccine Biological: recombinant vaccinia-B7.1 vaccine Biological: sargramostim Drug: nilutamide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase II Study of Either Immunotherapy With a Regimen of Recombinant Pox Viruses That Express PSA/B7.1 Plus Adjuvant GM-CSF and IL2 or Hormone Therapy With Nilutamide in Patients With Hormone Refractory Prostate Cancer and No Radiographic Evidence of Disease |
Study Start Date: | June 2000 |
Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
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.
Beginning on day 30, patients receive recombinant fowlpox-PSA vaccine SC every 4 weeks for 12 vaccinations and then every 12 weeks thereafter. Patients also receive sargramostim (GM-CSF) SC daily on days 1-4 and interleukin-2 SC daily on days 8-12 with each vaccination.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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:
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) |
Study ID Numbers: | CDR0000068106, NCI-00-C-0137, MB-NAVY-99-04, NCI-T99-0097 |
Study First Received: | July 11, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00020254 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer |
Anti-HIV Agents Genital Neoplasms, Male Prostatic Diseases Nilutamide Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Adjuvants, Immunologic Urogenital Neoplasms Genital Diseases, Male Antiviral Agents |
Hormones Recurrence Virus Diseases Androgen Antagonists Aldesleukin Anti-Retroviral Agents Interleukin-2 Adenocarcinoma Prostatic Neoplasms Androgens |
Anti-Infective Agents Anti-HIV Agents Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Nilutamide Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms |
Genital Diseases, Male Antiviral Agents Pharmacologic Actions Neoplasms Androgen Antagonists Neoplasms by Site Aldesleukin Anti-Retroviral Agents Therapeutic Uses Prostatic Neoplasms |