Trial | NCT00140374  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36
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.
Study Started
Dec 31
1998
Study Completion
Feb 28
2001
Last Update
Sep 01
2005
Estimate

Biological Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Criteria 

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
No Results Posted