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| Sponsored by: |
Cell Genesys |
| Information provided by: | Cell Genesys |
| ClinicalTrials.gov Identifier: | NCT00133224 |
Purpose
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.
As this is a survival trial and it is difficult to predict when deaths or the primary/secondary endpoints will occur, the anticipated completion dates provided represent the estimated completion of accrual, and the timeframes for the primary/secondary endpoints cannot be accurately estimated.
| Condition | Intervention | Phase |
|
Prostate Cancer |
Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine Drug: Chemotherapy (docetaxel and prednisone) |
Phase III |
| MedlinePlus related topics: | Prostate Cancer |
| ChemIDplus related topics: | Granulocyte-macrophage colony-stimulating factor Sargramostim Docetaxel Prednisone |
| 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 Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain |
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
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| 2 |
Drug: Chemotherapy (docetaxel and prednisone)
Chemotherapy (docetaxel and prednisone)
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations |
Show 103 Study Locations |
| Cell Genesys |
More Information
| Responsible Party: | Cell Genesys, Inc. ( Cell Genesys, Inc. ) |
| Study ID Numbers: | G-0034, VITAL-2 |
| First Received: | August 19, 2005 |
| Last Updated: | May 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00133224 |
| Health Authority: | United States: Food and Drug Administration |
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