- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00140348
Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine
December 18, 2007 updated by: Cell Genesys
A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
80
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Laguna Woods, California, United States, 92637
- South Orange County Medical Research Center
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San Francisco, California, United States, 94115
- UCSF
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Tarzana, California, United States, 91356
- West Coast Clinical Research
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Florida
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Aventura, Florida, United States, 33180
- South Florida Medical Research
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Illinois
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Urbana, Illinois, United States, 61801
- Carle Cancer Center
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Indiana
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Fort Wayne, Indiana, United States, 46825
- Northeast Indiana Research
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Texas
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San Antonio, Texas, United States, 78229
- Urology San Antonio
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Washington
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Seattle, Washington, United States, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, United States, 98101
- Virginia Mason Med. Crt.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2001
Study Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
August 30, 2005
First Submitted That Met QC Criteria
August 30, 2005
First Posted (Estimate)
September 1, 2005
Study Record Updates
Last Update Posted (Estimate)
December 24, 2007
Last Update Submitted That Met QC Criteria
December 18, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G-0010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
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