Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine
This study has been completed.
Sponsor:
Cell Genesys
Information provided by:
Cell Genesys
ClinicalTrials.gov Identifier:
NCT00140348
First received: August 30, 2005
Last updated: December 18, 2007
Last verified: December 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Cell Genesys:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00140348
Locations
| United States, California | |
| South Orange County Medical Research Center | |
| Laguna Woods, California, United States, 92637 | |
| UCSF | |
| San Francisco, California, United States, 94115 | |
| West Coast Clinical Research | |
| Tarzana, California, United States, 91356 | |
| United States, Florida | |
| South Florida Medical Research | |
| Aventura, Florida, United States, 33180 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| Northeast Indiana Research | |
| Fort Wayne, Indiana, United States, 46825 | |
| United States, Michigan | |
| University of Michigan Medical Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Pennsylvania | |
| Fox Chase cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, Texas | |
| Urology San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| United States, Washington | |
| Virginia Mason Med. Crt. | |
| Seattle, Washington, United States, 98101 | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
Cell Genesys
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00140348 History of Changes |
| Other Study ID Numbers: | G-0010 |
| Study First Received: | August 30, 2005 |
| Last Updated: | December 18, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cell Genesys:
|
Prostate Cancer Advanced Prostate Cancer Metastatic |
Hormone-refractory GVAX Vaccine Allogeneic cells |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013