drugset / Trial / NCT00140387

Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®)

NCT00140387 ↗

Phase 1/2 Completed 20 enrolled Cell Genesys
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®). Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of Allogeneic Prostate GVAX® on serum PSA levels will be evaluated and antitumor responses will be quantitated.

Timeline

Start
1999-05
Primary completion
—
Completion
2001-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Allogeneic Prostate GVAX® Vaccine — —

Indications