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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014