Vaccination Priming and Vaccine Boosting Trial of Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines (GVAX® Vaccine for Prostate Cancer)

This study has been completed.
Sponsor:
Information provided by:
Cell Genesys
ClinicalTrials.gov Identifier:
NCT00140374
First received: August 30, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted

August 30, 2005
August 30, 2005
December 1998
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Vaccination Priming and Vaccine Boosting Trial of Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines (GVAX® Vaccine for Prostate Cancer)
Phase I/II Study of Vaccination Priming and Vaccine Boosting With Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines in Patients With Prostate Cancer

The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with GVAX® Vaccine for Prostate Cancer. Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of GVAX® Vaccine for Prostate Cancer on serum PSA levels, will be evaluated and antitumor responses will be quantitated.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
February 2001
Not Provided

Inclusion Criteria:

  • Diagnosis of adenocarcinoma prostate cancer that has recurred after surgery by PSA
  • No evidence of measurable metastatic disease
  • An ECOG performance status of 0 or 1

Exclusion Criteria:

  • Transitional cell, small cell or squamous cell prostate carcinomas
  • Any previous radiation therapy, prior anti-androgens or prior investigational therapy
  • Previous hormonal therapy of any type for prostate cancer
  • Previous biological therapy for cancer
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00140374
G-9705A
Not Provided
Not Provided
Cell Genesys
Not Provided
Not Provided
Cell Genesys
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP