Back to resultsPrime-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
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate, Cancer, Advanced prostate cancer, Metastatic, Hormone-refractory, GVAX, Vaccine, Allogeneic cells
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00140400
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
May 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cell Genesys
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, Cancer, Advanced prostate cancer, Metastatic, Hormone-refractory, GVAX, Vaccine, Allogeneic cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
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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