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Tumor RNA Transfected Dendritic Cell Vaccines

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108264
First received: April 14, 2005
Last updated: January 20, 2009
Last verified: May 2007
History of Changes
  Purpose

The purpose of this study is to use dendritic cells transfected with amplified RNA from autologous tumor cells to develop a vaccine strategy for the treatment of prostate cancer in patients with disseminated disease.


Condition Intervention Phase
Prostate Cancer
 Biological: Tumor RNA transfected dendritic cells
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Tumor RNA Transfected Dendritic Cell Vaccines

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Estimated Study Completion Date: September 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108264

Locations
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Department of Veterans Affairs
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00108264     History of Changes
Other Study ID Numbers: CLIN-021-02S
Study First Received: April 14, 2005
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Prostatic Neoplasms
Neoplasm Metastasis
Immunotherapy
Active
Dendritic Cells

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013