Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00004211|
Recruitment Status : Completed
First Posted : May 20, 2004
Last Update Posted : March 21, 2013
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: PSA RNA-pulsed dendritic cell vaccine||Phase 1 Phase 2|
OBJECTIVES: I. Determine the safety and feasibility of prostate specific antigen (PSA) RNA pulsed autologous dendritic cells in patients with metastatic prostate cancer. II. Evaluate the presence and magnitude of cellular immune responses against PSA as a surrogate target for immune activation in this patient population. III. Assess the presence, frequency, and activation status of peripheral cytotoxic T lymphocytes prior to and following immunotherapy with this regimen in these patients. IV. Evaluate humoral immune responses as evidenced on circulating peripheral PSA specific antibodies in this patient population. V. Evaluate delayed type hypersensitivity reactions to irradiated PSA RNA transfected dendritic cells and other standard recall antigens prior to and following immunotherapy in these patients. VI. Evaluate eventual clinical responses as evidenced on clinical and biochemical (PSA) response criteria.
OUTLINE: This is a dose escalation study. Patients receive prostate specific antigen (PSA) RNA pulsed autologous dendritic cells IV over 2 minutes followed by PSA RNA dendritic cells intradermally on weeks 0, 2, and 4 for a total of 3 treatments. Cohorts of 3-6 patients receive escalating doses of PSA RNA pulsed autologous dendritic cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed weekly for 3 months, then every 3 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 24 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Official Title:||A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With RNA Encoding Prostate Specific Antigen, PSA|
|Study Start Date :||July 1999|
|Actual Study Completion Date :||January 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004211
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Johannes Vieweg, MD||Duke Cancer Institute|