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
  Purpose

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.


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: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cell Genesys:

Estimated Enrollment: 36
Study Start Date: December 1998
Estimated Study Completion Date: February 2001
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00140374     History of Changes
Other Study ID Numbers: G-9705A
Study First Received: August 30, 2005
Last Updated: August 30, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Cell Genesys:
Prostate
Cancer
Vaccine
GVAX
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 April 15, 2014