drugset / Trial / NCT00140400

Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Patients With Hormone-Refractory Prostate Cancer

NCT00140400 ↗

Phase 1/2 Completed 50 enrolled Cell Genesys
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The objective of this study is to evaluate the safety and efficacy of a prime-boost dose schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) as measured by standard toxicity evaluation, changes in PSA, and tumor responses. Additional objectives are to measure the time to PSA and/or clinical disease progression as well as local and systemic immune responses to the vaccine.

Timeline

Start
1999-05
Primary completion
—
Completion
2001-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Allogeneic Prostate GVAX® Vaccine — —

Indications