Back to resultsPrime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®)
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, GVAX, Metastatic, Vaccine, Allogeneic cells
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00140387
Brief Title
Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®)
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 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
March 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, Cancer, GVAX, Metastatic, 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
20 (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
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
12. IPD Sharing Statement
Learn more about this trial
Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®)
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