Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

This study has been completed.
Sponsor:
Information provided by:
Cell Genesys
ClinicalTrials.gov Identifier:
NCT00140348
First received: August 30, 2005
Last updated: December 18, 2007
Last verified: December 2007
  Purpose

The purpose of this study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated dose.


Condition Intervention Phase
Prostate Cancer
Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Cell Genesys:

Estimated Enrollment: 80
Study Start Date: December 2001
Study Completion Date: April 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of adenocarcinoma of the prostate
  • Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
  • Detectable metastases
  • ECOG performance status of 0 or 1

Exclusion Criteria:

  • Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
  • Significant cancer related pain
  • Prior gene therapy, chemotherapy, or immunotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140348

Locations
United States, California
South Orange County Medical Research Center
Laguna Woods, California, United States, 92637
UCSF
San Francisco, California, United States, 94115
West Coast Clinical Research
Tarzana, California, United States, 91356
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Northeast Indiana Research
Fort Wayne, Indiana, United States, 46825
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, Pennsylvania
Fox Chase cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Urology San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Virginia Mason Med. Crt.
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Cell Genesys
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00140348     History of Changes
Other Study ID Numbers: G-0010
Study First Received: August 30, 2005
Last Updated: December 18, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014