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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

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ClinicalTrials.gov Identifier: NCT00140400
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : September 1, 2005
Sponsor:
Information provided by:

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 Vaccine (Allogeneic Prostate GVAX®) in Hormone-Refractory Prostate Cancer
Study Start Date : May 1999
Estimated Study Completion Date : January 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

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
More Information

ClinicalTrials.gov Identifier: NCT00140400     History of Changes
Other Study ID Numbers: G-9803
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: September 1, 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