Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00010127
- Lead Sponsor
- Duke University
- Brief Summary
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill prostate tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer.
- Detailed Description
OBJECTIVES:
* Determine the safety and feasibility of autologous dendritic cells transfected with autologous total tumor RNA in patients with metastatic prostate cancer.
* Determine the presence, frequency, and activation status of tumor specific and prostate specific antigen (PSA) specific cellular immune responses in patients treated with this regimen.
* Determine delayed-type hypersensitivity reactions to PSA protein and other recall antigens in patients before and after being treated with this regimen.
* Determine clinical responses based on clinical and biochemical (PSA) response criteria in patients treated with this regimen.
* Determine a platform for immunological treatment using dendritic-cell based tumor vaccines in these patients.
OUTLINE: This is a dose escalation study.
Tumor tissue and peripheral blood stem cells are collected from patients and cultured in vitro with sargramostim (GM-CSF) and interleukin-4 for 7 days to produce dendritic cells (DC). Patients receive autologous DC transfected with autologous prostate carcinoma RNA intradermally once weekly on weeks 0-3 for a total of 4 doses.
Cohorts of 3-6 patients receive escalating doses of DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at weeks 6, 8, 10, and 12; every 3 months for 9 months; and then annually for 2 years.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study within 20 months.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 3
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Duke Comprehensive Cancer Center🇺🇸Durham, North Carolina, United States