A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
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 |
