Phase I/II Study of Vaccination Priming and Vaccine Boosting With Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines in Patients With Prostate Cancer

Cell Genesys0 sites36 target enrollmentDecember 1998

ConditionsProstate Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Cell Genesys
Enrollment: 36
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with GVAX® Vaccine for Prostate Cancer. Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of GVAX® Vaccine for Prostate Cancer on serum PSA levels, will be evaluated and antitumor responses will be quantitated.

Registry

clinicaltrials.gov

Start Date

December 1998

End Date

February 2001

Last Updated

20 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Cell Genesys

Eligibility Criteria

Inclusion Criteria

•Diagnosis of adenocarcinoma prostate cancer that has recurred after surgery by PSA
•No evidence of measurable metastatic disease
•An ECOG performance status of 0 or 1

Exclusion Criteria

•Transitional cell, small cell or squamous cell prostate carcinomas
•Any previous radiation therapy, prior anti-androgens or prior investigational therapy
•Previous hormonal therapy of any type for prostate cancer
•Previous biological therapy for cancer