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Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Patients With Hormone-Refractory Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00140400
First Posted: September 1, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cell Genesys
  Purpose
The objective of this study is to evaluate the safety and efficacy of a prime-boost dose schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) as measured by standard toxicity evaluation, changes in PSA, and tumor responses. Additional objectives are to measure the time to PSA and/or clinical disease progression as well as local and systemic immune responses to the vaccine.

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
Intervention Model: Single Group Assignment
Masking: None (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 Vaccine (Allogeneic Prostate GVAX®) in Hormone-Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Cell Genesys:

Estimated Enrollment: 50
Study Start Date: May 1999
Estimated Study Completion Date: January 2001
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of adenocarcinoma prostate cancer
  • Prostate cancer deemed to be unresponsive or refractory to hormone therapy
  • An ECOG performance status of 0 or 1

Exclusion Criteria:

  • Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
  • Previous chemotherapy, biological or immunotherapy for cancer
  • Previous gene therapy for cancer
  • Significant cancer related pain
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00140400     History of Changes
Other Study ID Numbers: G-9803
First Submitted: August 30, 2005
First Posted: September 1, 2005
Last Update Posted: December 9, 2005
Last Verified: August 2005

Keywords provided by Cell Genesys:
Prostate
Cancer
Advanced prostate cancer
Metastatic
Hormone-refractory
GVAX
Vaccine
Allogeneic cells

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Vaccines
Hormones
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists