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

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. Identifier: NCT00140387
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : September 1, 2005
Information provided by:
Cell Genesys

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
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 Cell Vaccines (Allogeneic Prostate GVAX®) in Hormone-naïve Prostate Cancer Patients
Study Start Date : May 1999
Study Completion Date : March 2001

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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

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 Identifier: NCT00140387     History of Changes
Other Study ID Numbers: G-9802
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: September 1, 2005
Last Verified: August 2005

Keywords provided by Cell Genesys:
Allogeneic cells

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Immunologic Factors
Physiological Effects of Drugs