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Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Sponsored by
Cell Genesys
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of adenocarcinoma of the prostate Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy Detectable metastases ECOG performance status of 0 or 1 Exclusion Criteria: Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer Significant cancer related pain Prior gene therapy, chemotherapy, or immunotherapy

Sites / Locations

  • South Orange County Medical Research Center
  • UCSF
  • West Coast Clinical Research
  • South Florida Medical Research
  • Emory University
  • Carle Cancer Center
  • Northeast Indiana Research
  • University of Michigan Medical Center
  • Fox Chase cancer Center
  • Urology San Antonio
  • Virginia Mason Med. Crt.
  • Seattle Cancer Care Alliance

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 30, 2005
Last Updated
December 18, 2007
Sponsor
Cell Genesys
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1. Study Identification

Unique Protocol Identification Number
NCT00140348
Brief Title
Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine
Official Title
A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cell Genesys

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated dose.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (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 of the prostate Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy Detectable metastases ECOG performance status of 0 or 1 Exclusion Criteria: Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer Significant cancer related pain Prior gene therapy, chemotherapy, or immunotherapy
Facility Information:
Facility Name
South Orange County Medical Research Center
City
Laguna Woods
State/Province
California
ZIP/Postal Code
92637
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
West Coast Clinical Research
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Northeast Indiana Research
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Fox Chase cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Urology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Mason Med. Crt.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

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Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

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