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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Closed

18 and over

Pharmaceutical / Industry

G-0029
(VITAL-1), NCT00089856

Trial Description

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.

As this is a survival trial and it is difficult to predict when deaths or the primary/secondary endpoints will occur, the anticipated completion dates provided represent the actual completion of accrual, and the timeframes for the primary/secondary endpoints cannot be accurately estimated.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cell Genesys, Incorporated

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00089856
Information obtained from ClinicalTrials.gov on February 27, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.