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

This study has been terminated.
(Based on futility analysis showing <30% chance of meeting primary endpoint.)
Sponsor:
Information provided by:
Cell Genesys
ClinicalTrials.gov Identifier:
NCT00089856
First received: August 16, 2004
Last updated: November 3, 2008
Last verified: November 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Biological: Immunotherapy with allogeneic prostate vaccine
Drug: Chemotherapy (Taxotere and prednisone)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cell Genesys:

Primary Outcome Measures:
  • Survival [ Time Frame: 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone pain and bone related events [ Time Frame: 0 ] [ Designated as safety issue: No ]

Enrollment: 626
Study Start Date: July 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2
Standard of care - chemotherapy
 Drug: Chemotherapy (Taxotere and prednisone)
Chemotherapy (Taxotere and prednisone)
Experimental: 1
Immunotherapy
 Biological: Immunotherapy with allogeneic prostate vaccine
Immunotherapy with allogeneic prostate vaccine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089856

  Show 126 Study Locations
Sponsors and Collaborators
Cell Genesys
  More Information

No publications provided

Responsible Party: Cell Genesys, Inc, Cell Genesys, Inc.
ClinicalTrials.gov Identifier: NCT00089856     History of Changes
Other Study ID Numbers: G-0029, (VITAL-1)
Study First Received: August 16, 2004
Last Updated: November 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Cell Genesys:
Prostate
Cancer
Metastatic
Hormone-refractory
GVAX
Chemotherapy
 Taxotere
Docetaxel
Prednisone
Vaccine
Allogeneic cells
Advanced Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Prednisone
 Docetaxel
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013