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Tumor RNA Transfected Dendritic Cell Vaccines


Phase 1
10 Years
N/A
Not Enrolling
Male
Prostate Cancer

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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 CenterDurham, North Carolina  27705