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Clinical Trials/NCT00004029
NCT00004029CompletedPhase 1

A PHASE I TRIAL OF RECOMBINANT VACCINIA VIRUS THAT EXPRESSES PSA IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE

National Cancer Institute (NCI)6 sites in 1 country46 target enrollmentStarted: December 1996Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
46
Locations
6

Study Overview

Brief Summary

Phase I trial to study the effectiveness of vaccine therapy in treating patients with metastatic prostate cancer. Vaccines may make the body build an immune response to kill tumor cells.

Detailed Description

OBJECTIVES:

I. Assess the toxicity associated with repeated vaccination with recombinant vaccinia virus expressing prostate-specific antigen (rV-PSA) in patients with metastatic adenocarcinoma of the prostate.

II. Determine the optimal dose of rV-PSA given at monthly intervals based on cellular and hormonal immunity.

III. Determine whether vaccination with rV-PSA is associated with anti-tumor activity.

IV. Determine whether granulocyte-macrophage colony-stimulating factor (GM-CSF) has an effect on cellular and humoral immunity different from rV-PSA, and whether the addition of GM-CSF has enhanced antitumor effect compared to rV-PSA alone.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Nih
Responsible Party
Sponsor

Study Sites (6)

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