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A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA

NCT00006430 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2005-06-24

No results posted yet for this study

Summary

Purpose: This protocol proposes a safety and feasibility trial in patients with metastatic prostate cancer (stages D1-D3) investigating the induction of antitumor immunity by administration of cultured autologous peripheral blood precursor derived dendritic cells (DC), transfected with mRNA amplified from autologous prostate tumor tissue. The feasibility and dose-limiting toxicity of administering escalating doses of tumor RNA transfected dendritic cells will be defined. As a secondary endpoint, the ability of tumor RNA transfected dendritic cells to induce tumor-specific immune responses will be evaluated. Finally, the anti-tumor effect based on PSA (biochemical) response criteria will be defined.

Background: Because prostate cancer is incurable when metastatic and conventional therapies do not offer a clear survival benefit, new therapeutic strategies are warranted. This study is based on the premise that clinically effective cell mediated immune responses against prostate tumors can be elicited by activation of tumor associated antigen specific T cells. Work performed by others and our group suggests that PSA, a protein expressed in virtually all prostate cancers, can serve as a widely expressed candidate antigen for prostate cancer immunotherapy. In particular, we have shown that cultured dendritic cells transfected with mRNA encoding PSA are remarkably effective in stimulating antigen specific immunity in vitro. Therefore, we hypothesize that administration of PSA RNA transfected DC will lead to detectable levels of PSA specific CTL in the peripheral blood of patients with PSA expressing metastatic prostate cancer. It is hoped that these T cell responses also have clinical antitumor activity.

Conditions

Interventions

BIOLOGICAL

Autologous dendritic cells transfected with amplified tumor RNA

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • National Center for Research Resources (NCRR)

    lead NIH

Principal Investigators

  • Johannes Vieweg, M.D. · Duke University

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006430 on ClinicalTrials.gov