Tumor RNA Transfected Dendritic Cell Vaccines

Prostate Cancer Clinical Trial

Official title:

Tumor RNA Transfected Dendritic Cell Vaccines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00108264
• Other study ID #: CLIN-021-02S
• Status: Completed
• Phase: Phase 1
• First received: April 14, 2005
• Last updated: January 20, 2009
• Est. completion date: September 2005

Study information

• Verified date: May 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 10 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Biological:
• Tumor RNA transfected dendritic cells

Locations

Country	Name	City	State
United States	Durham VA Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,