Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

Trial Information

A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

G-0010

NCT ID:

NCT00140348

Start Date:

December 2001

Completion Date:

April 2005

Related Keywords:

Prostate Cancer
Prostate
Cancer
Advanced Prostate Cancer
Metastatic
Hormone-refractory
GVAX
Vaccine
Allogeneic cells
Prostatic Neoplasms

Name	Location
UCSF	San Francisco, California 941430324
Fox Chase Cancer Center	Philadelphia, Pennsylvania 19111
Carle Cancer Center	Urbana, Illinois 61801
Seattle Cancer Care Alliance	Seattle, Washington 98109
University of Michigan Medical Center	Ann Arbor, Michigan 48104-0914
Emory University	Atlanta, Georgia 30322
South Florida Medical Research	Aventura, Florida 33180
Northeast Indiana Research	Fort Wayne, Indiana 46804-4128
South Orange County Medical Research Center	Laguna Hills, California 92653
Urology San Antonio	San Antonio, Texas 78229
West Coast Clinical Research	Tarzana, California 91356
Virginia Mason Med. Crt.	Seattle, Washington 98101

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