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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005039 |
RATIONALE: Vaccines made from a person's prostate cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase II trial to determine the effectiveness of vaccine therapy in treating patients who have advanced adenocarcinoma of the prostate (prostate cancer).
Condition | Intervention | Phase |
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Prostate Cancer |
Biological: recombinant fowlpox-prostate apecific antigen vaccine Biological: recombinant vaccinia prostate-specific antigen vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Phase II Randomized Trial of Recombinant Fowlpox and Recombinant Vaccinia Virus Expressing PSA in Patients With Adenocarcinoma of the Prostate |
Study Start Date: | January 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter, dose-escalation study of recombinant fowlpox prostate-specific antigen (PSA) vaccine.
Subsequent patients are assigned to one of two vaccination groups based on prior treatment with recombinant vaccinia-PSA vaccine:
Group A (no prior recombinant vaccinia-PSA vaccine): Patients are randomized to one of two vaccination arms:
Patients are followed monthly for 6 months and then every 3 months thereafter.
PROJECTED ACCRUAL: Approximately 6-86 patients (6 in the safety cohort, 15-20 per arm in group A, and approximately 10 in group B) will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma of the prostate with evidence of metastatic disease including any of the following:
Prior cryosurgery and PSA at least 10 ng/mL
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Immunologic:
No autoimmune diseases such as the following:
Other:
No close contact or household contact with the following high-risk individuals for at least 2 weeks after each vaccination:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Study Chair: | Joseph Paul Eder, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000067630, DFCI-98262, NCI-T98-0004 |
Study First Received: | April 6, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005039 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Virus Diseases Prostatic Diseases Genital Neoplasms, Male Vaccinia Urogenital Neoplasms Genital Diseases, Male |
Adenocarcinoma Prostatic Neoplasms Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Neoplasms, Glandular and Epithelial Carcinoma |