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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00062153 |
Purpose
RATIONALE: 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.
PURPOSE: 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: fowlpox-PSA-TRICOM vaccine Biological: recombinant fowlpox GM-CSF vaccine adjuvant Biological: sargramostim Biological: vaccinia-PSA-TRICOM vaccine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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 |
| Estimated Enrollment: | 62 |
| Study Start Date: | May 2003 |
| Estimated Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a pilot phase I dose-escalation study (phase I closed to accrual as of 6/2/04) followed by a randomized phase II study.
Phase I (closed to accrual as of 6/2/04): Cohorts of 3-6 patients are sequentially assigned to 1 of 5 treatment regimens to determine the optimal regimen. The optimal regimen is defined as the regimen preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Phase II: Patients are randomized to 1 of 4 treatment arms, based on the assumption that all 5 regimen levels in phase I are completed.
After completion of study treatment, patients are followed annually for 15 years.
PROJECTED ACCRUAL: A maximum of 62 patients (up to 30 for phase I [closed to accrual as of 6/2/04] and a total of 32 [8 per treatment arm] for phase II) will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer, meeting the following criteria:
Progression after prior standard hormonal therapy for metastatic prostate cancer
Objective evidence of metastasis or relapsing local disease as evidenced by a rising PSA and at least 1 of the following:
The following positive imaging studies:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
No acute, chronic, or exfoliative skin conditions, including:
No close household contact with persons meeting any of the following criteria for at least 3 weeks after vaccination:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
More than 3 years since prior therapy with any of the following (phase II only):
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 | |
| Principal Investigator: | James Gulley, MD, PhD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000304524, NCI-03-C-0176, NCI-5911 |
| Study First Received: | June 5, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00062153 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent prostate cancer stage IV prostate cancer |
|
Metronidazole Prostatic Diseases Genital Neoplasms, Male Adjuvants, Immunologic |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Recurrence |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |