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Sponsored by: |
Cell Genesys |
---|---|
Information provided by: | Cell Genesys |
ClinicalTrials.gov Identifier: | NCT00089856 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Biological: Immunotherapy with allogeneic prostate vaccine Drug: Chemotherapy (Taxotere and prednisone) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 626 |
Study Start Date: | July 2004 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
2
Standard of care - chemotherapy
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Drug: Chemotherapy (Taxotere and prednisone)
Chemotherapy (Taxotere and prednisone)
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1: Experimental
Immunotherapy
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Biological: Immunotherapy with allogeneic prostate vaccine
Immunotherapy with allogeneic prostate vaccine
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Cell Genesys, Inc. ( Cell Genesys, Inc ) |
Study ID Numbers: | G-0029, (VITAL-1) |
Study First Received: | August 16, 2004 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00089856 |
Health Authority: | United States: Food and Drug Administration |
Prostate Cancer Metastatic Hormone-refractory GVAX Chemotherapy |
Taxotere Docetaxel Prednisone Vaccine Allogeneic cells Advanced Prostate Cancer |
Docetaxel Prednisone Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Anti-Inflammatory Agents Neoplasms Neoplasms by Site Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids Pharmacologic Actions |