Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00010127|
Recruitment Status : Terminated
First Posted : July 30, 2003
Last Update Posted : March 21, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: therapeutic autologous dendritic cells||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Official Title:||A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA|
|Study Start Date :||November 2000|
|Actual Study Completion Date :||March 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010127
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Johannes Vieweg, MD||Duke Cancer Institute|