Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140387
Status:
COMPLETED
Last Update Posted:
2005-09-01
First Post:
2005-08-30
Brief Title:
Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines Allogeneic Prostate GVAX
Sponsor:
Cell Genesys
Organization:
Cell Genesys
Study Overview
Official Title:
Phase III Study of a Prime-Boost Schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines Allogeneic Prostate GVAX in Hormone-naïve Prostate Cancer Patients
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the safety and efficacy of priming vaccinations and subsequent boosting vaccinations with Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines Allogeneic Prostate GVAX Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity Additionally the antitumor effects of Allogeneic Prostate GVAX on serum PSA levels will be evaluated and antitumor responses will be quantitated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None