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Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

Phase 1
Completed
Conditions
Prostate Cancer
Registration Number
NCT00140348
Lead Sponsor
Cell Genesys
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
80
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (12)

South Florida Medical Research

🇺🇸

Aventura, Florida, United States

Northeast Indiana Research

🇺🇸

Fort Wayne, Indiana, United States

Seattle Cancer Care Alliance

🇺🇸

Seattle, Washington, United States

Fox Chase cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

Emory University

🇺🇸

Atlanta, Georgia, United States

UCSF

🇺🇸

San Francisco, California, United States

West Coast Clinical Research

🇺🇸

Tarzana, California, United States

University of Michigan Medical Center

🇺🇸

Ann Arbor, Michigan, United States

Urology San Antonio

🇺🇸

San Antonio, Texas, United States

South Orange County Medical Research Center

🇺🇸

Laguna Woods, California, United States

Carle Cancer Center

🇺🇸

Urbana, Illinois, United States

Virginia Mason Med. Crt.

🇺🇸

Seattle, Washington, United States

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