Back to resultsVaccination Priming and Vaccine Boosting Trial of Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines (GVAX® Vaccine for 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, Vaccine, GVAX, Allogeneic cells
Eligibility Criteria
Inclusion Criteria: Diagnosis of adenocarcinoma prostate cancer that has recurred after surgery by PSA No evidence of measurable metastatic disease An ECOG performance status of 0 or 1 Exclusion Criteria: Transitional cell, small cell or squamous cell prostate carcinomas Any previous radiation therapy, prior anti-androgens or prior investigational therapy Previous hormonal therapy of any type for prostate cancer Previous biological therapy for cancer
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00140374
Brief Title
Vaccination Priming and Vaccine Boosting Trial of Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines (GVAX® Vaccine for Prostate Cancer)
Official Title
Phase I/II Study of Vaccination Priming and Vaccine Boosting With Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines in Patients With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 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 GVAX® Vaccine for Prostate Cancer. Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of GVAX® Vaccine for Prostate Cancer 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, Vaccine, GVAX, 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
36 (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 that has recurred after surgery by PSA
No evidence of measurable metastatic disease
An ECOG performance status of 0 or 1
Exclusion Criteria:
Transitional cell, small cell or squamous cell prostate carcinomas
Any previous radiation therapy, prior anti-androgens or prior investigational therapy
Previous hormonal therapy of any type for prostate cancer
Previous biological therapy for cancer
12. IPD Sharing Statement
Learn more about this trial
Vaccination Priming and Vaccine Boosting Trial of Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines (GVAX® Vaccine for Prostate Cancer)
We'll reach out to this number within 24 hrs