Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine - Full Text View

Sponsored by:	Cell Genesys
Information provided by:	Cell Genesys
ClinicalTrials.gov Identifier:	NCT00140348

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 I Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Official Title:	A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer

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

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

Locations

United States, California
West Coast Clinical Research
Tarzana, California, United States, 91356
UCSF
San Francisco, California, United States, 94115
South Orange County Medical Research Center
Laguna Woods, California, United States, 92637
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
Virginia Mason Med. Crt.
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109

Sponsors and Collaborators

Cell Genesys

More Information

Study ID Numbers:	G-0010
Study First Received:	August 30, 2005
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00140348
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

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 13, 2009