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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005039 |
Purpose
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 |
|---|---|---|
|
Prostate Cancer |
Biological: recombinant fowlpox-prostate specific antigen vaccine Biological: recombinant vaccinia prostate-specific antigen vaccine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00005039 History of Changes |
| Other Study ID Numbers: | CDR0000067630, DFCI-98262, NCI-T98-0004 |
| Study First Received: | April 6, 2000 |
| Last Updated: | October 30, 2010 |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
|
Adenocarcinoma Prostatic Neoplasms Vaccinia Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Genital Neoplasms, Male |
Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Poxviridae Infections DNA Virus Infections Virus Diseases |