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CompletedNCT00140348Updated Dec 24, 2007

Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

A Phase 1/2 interventional study of Immunotherapy allogeneic GM-CSF secreting cellular vaccine in Prostate Cancer, sponsored by Cell Genesys. Completed at 12 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-12-24.

Sponsored by Cell Genesys · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate
  • Cancer
  • Advanced Prostate Cancer
  • Metastatic
  • Hormone-refractory
  • GVAX
  • Vaccine
  • Allogeneic cells
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 80 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Cell Genesys is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
  • Significant cancer related pain
  • Prior gene therapy, chemotherapy, or immunotherapy
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants

Interventions

  • BiologicalImmunotherapy allogeneic GM-CSF secreting cellular vaccine
06

Study locations

12 sites
  • South Orange County Medical Research Center
    Laguna Woods, California 92637, United States
  • UCSF
    San Francisco, California 94115, United States
  • West Coast Clinical Research
    Tarzana, California 91356, United States
  • South Florida Medical Research
    Aventura, Florida 33180, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • Carle Cancer Center
    Urbana, Illinois 61801, United States
  • Northeast Indiana Research
    Fort Wayne, Indiana 46825, United States
  • University of Michigan Medical Center
    Ann Arbor, Michigan 48109, United States
  • Fox Chase cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • Urology San Antonio
    San Antonio, Texas 78229, United States
  • Virginia Mason Med. Crt.
    Seattle, Washington 98101, United States
  • Seattle Cancer Care Alliance
    Seattle, Washington 98109, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00140348
Lead sponsor
Cell Genesys
First posted
Sep 1, 2005
Start date
Dec 2001
Completion
Apr 2005
Last update
Dec 24, 2007
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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