Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®)

This study has been completed.
Sponsor:
Information provided by:
Cell Genesys
ClinicalTrials.gov Identifier:
NCT00140387
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 Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®). Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of Allogeneic Prostate GVAX® 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 a Prime-Boost Schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®) in Hormone-naïve Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Cell Genesys:

Estimated Enrollment: 20
Study Start Date: May 1999
Estimated Study Completion Date: March 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
  • No evidence of measurable metastatic disease
  • An ECOG performance status of 0 or 1

Exclusion Criteria:

  • Previous hormonal therapy of any type for prostate cancer
  • Any previous chemotherapy, or prior investigational therapy for prostate cancer
  • Prior Immunotherapy
  • Prior treatment with gene therapy
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00140387     History of Changes
Other Study ID Numbers: G-9802
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
GVAX
Metastatic
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 April 17, 2014