A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer

Cell Genesys12 sites in 1 country80 target enrollmentDecember 2001

ConditionsProstate Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Cell Genesys
Enrollment: 80
Locations: 12
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated dose.

Registry

clinicaltrials.gov

Start Date

December 2001

End Date

April 2005

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Cell Genesys

Eligibility Criteria

Inclusion Criteria

•Diagnosis of adenocarcinoma of the prostate
•Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
•Detectable metastases
•ECOG performance status of 0 or 1

Exclusion Criteria

•Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
•Significant cancer related pain
•Prior gene therapy, chemotherapy, or immunotherapy