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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045227 |
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or without docetaxel in treating patients who have metastatic prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: docetaxel Drug: recombinant fowlpox-prostate apecific antigen vaccine Drug: recombinant vaccinia prostate-specific antigen vaccine Drug: recombinant vaccinia-B7.1 vaccine Drug: sargramostim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Pilot Trial of Pox Vector PSA Vaccine With Concurrent Docetaxel Versus Pox Vector Vaccine Followed by Docetaxel in Metastatic Androgen Independent Prostate Cancer |
Study Start Date: | August 2002 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms after receiving priming vaccinations.
PROJECTED ACCRUAL: A total of 28 patients (14 per treatment arm) will be accrued for this study within 9-10 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of androgen-independent metastatic adenocarcinoma of the prostate, confirmed by 1 of the following:
Castrate levels of testosterone with progressive disease by at least 1 of the following parameters:
Progression of soft-tissue metastases by imaging or palpation, as indicated by:
Serum testosterone less than 50 ng/dL if no prior surgical castration
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
No altered immune function, including:
Autoimmune disease
Other
No household or close physical contact with persons with any of the following conditions during or for 2 weeks after study treatment:
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: | CDR0000256919, NCI-02-C-0218, NCI-5319 |
Study First Received: | September 6, 2002 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00045227 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
Docetaxel Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |