GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

• Status: Terminated
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cell Genesys
• Treatments: Docetaxel; Hormones; Prednisone; Vaccines

Criteria

Inclusion Criteria:

• Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate

• Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy

• Detectable metastases

• Any Gleason score

• ECOG performance status 0-2

Exclusion Criteria:

• Prior treatment with chemotherapy

• Prior Immunotherapy

• Prior treatment with gene therapy

• Significant cancer related pain