Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-04-06 @ 5:52 PM
Study NCT ID:
NCT00089856
Status:
TERMINATED
Last Update Posted:
2008-11-05
First Post:
2004-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer
Sponsor:
Organization:
Raw JSON
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Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer. Oncologist. 2013 Jun;18(6):687-8. doi: 10.1634/theoncologist.2011-0234. Epub 2013 Jun 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate\n* Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy\n* Detectable metastases\n* Any Gleason score\n* ECOG performance status 0-2\n\nExclusion Criteria:\n\n* Prior treatment with chemotherapy\n* Prior Immunotherapy\n* Prior treatment with gene therapy\n* Significant cancer related pain'}, 'identificationModule': {'nctId': 'NCT00089856', 'briefTitle': 'GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cell Genesys'}, 'officialTitle': 'A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve', 'orgStudyIdInfo': {'id': 'G-0029'}, 'secondaryIdInfos': [{'id': '(VITAL-1)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '2', 'description': 'Standard of care - chemotherapy', 'interventionNames': ['Drug: Chemotherapy (Taxotere and prednisone)']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Immunotherapy', 'interventionNames': ['Biological: Immunotherapy with allogeneic prostate vaccine']}], 'interventions': [{'name': 'Immunotherapy with allogeneic prostate vaccine', 'type': 'BIOLOGICAL', 'description': 'Immunotherapy with allogeneic prostate vaccine', 'armGroupLabels': ['1']}, {'name': 'Chemotherapy (Taxotere and prednisone)', 'type': 'DRUG', 'description': 'Chemotherapy (Taxotere and prednisone)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35007', 'city': 'Alabaster', 'state': 'Alabama', 'country': 'United States', 'facility': 'Central Alabama Oncology, LLC', 'geoPoint': {'lat': 33.24428, 'lon': -86.81638}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Clinical Research Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85304', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Palo Verde Hematology/Oncology', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85715', 'city': 'Tuscon', 'state': 'Arizona', 'country': 'United States', 'facility': 'ACRC/Arizona Clinical Res. 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