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NCT00140348 Clinical Trial

Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00140348
Other study ID # G-0010
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 30, 2005
Last updated December 18, 2007
Start date December 2001
Est. completion date April 2005

Study information
Verified date December 2007
Source Cell Genesys
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Biological:
• Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Locations
Country Name City State
United States University of Michigan Medical Center Ann Arbor Michigan
United States Emory University Atlanta Georgia
United States South Florida Medical Research Aventura Florida
United States Northeast Indiana Research Fort Wayne Indiana
United States South Orange County Medical Research Center Laguna Woods California
United States Fox Chase cancer Center Philadelphia Pennsylvania
United States Urology San Antonio San Antonio Texas
United States UCSF San Francisco California
United States Seattle Cancer Care Alliance Seattle Washington
United States Virginia Mason Med. Crt. Seattle Washington
United States West Coast Clinical Research Tarzana California
United States Carle Cancer Center Urbana Illinois

Sponsors (1)
Lead Sponsor Collaborator
Cell Genesys

Country where clinical trial is conducted

United States, 

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