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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  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 July 29, 2014