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A Phase III Randomized, Open-Label Study of Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain
The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Alaska Clinical Research Center
Anchorage, Alaska, United States
St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States
Loma Linda University
Loma Linda, California, United States
Onocology Care Medical Associates
Los Angeles, California, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States
San Bernardino Urology Associates
San Bernardino, California, United States
Kaiser Permanente Medical Group Dept. of Oncology Research
San Diego, California, United States
Sharp Healthcare
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
UCSF Mt. Zion Cancer Center
San Francisco, California, United States
Start Date
July 1, 2005
Primary Completion Date
August 1, 2008
Completion Date
June 1, 2009
Last Updated
September 23, 2008
408
ACTUAL participants
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
BIOLOGICAL
Chemotherapy (docetaxel and prednisone)
DRUG
Lead Sponsor
Cell Genesys
NCT05691465
NCT06842498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04550494