Trial Information
Tumor RNA Transfected Dendritic Cell Vaccines
The specific aims are: 1) to evaluate, in a phase I clinical trial, the safety of
vaccinating patients with dendritic cells transfected with RNA from autologous cancer cells;
2) to analyze the T cell responses induced by the treatment; and 3) to improve the efficacy
of the treatment by developing methods to increase the induction of CD4+T cell responses.
Inclusion Criteria:
- Patients with a histologically confirmed diagnosis of metastatic prostate cancer
stages D1 - D3 are eligible for this study.
- They must not have a history of autoimmune disease, serious intercurrent chronic or
acute illness, pulmonary disease, active hepatitis, serologic evidence for HIV, or be
receiving corticosteroid or immunosuppressive therapy.
Exclusion Criteria:
- Patients will be excluded from the study if they have received chemotherapy or other
forms of immunotherapy in the 6 weeks prior to study entry.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Authority:
United States: Federal Government
Study ID:
CLIN-021-02S
NCT ID:
NCT00108264
Start Date:
Completion Date:
September 2005
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
- Neoplasm Metastasis
- Immunotherapy
- Active
- Dendritic Cells
- Prostatic Neoplasms
Name | Location |
---|
Durham VA Medical Center | Durham, North Carolina 27705 |