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

Overview

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.

Full Title of Study: “A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2008

Interventions

  • Biological: Immunotherapy with allogeneic prostate vaccine
    • Immunotherapy with allogeneic prostate vaccine
  • Drug: Chemotherapy (Taxotere and prednisone)
    • Chemotherapy (Taxotere and prednisone)

Arms, Groups and Cohorts

  • Other: 2
    • Standard of care – chemotherapy
  • Experimental: 1
    • Immunotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Survival
    • Time Frame: 0

Secondary Measures

  • Bone pain and bone related events
    • Time Frame: 0

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cell Genesys
  • Provider of Information About this Clinical Study
    • Cell Genesys, Inc, Cell Genesys, Inc.

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