Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140400
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 Vaccine Allogeneic Prostate GVAX in Patients With Hormone-Refractory Prostate Cancer
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 Vaccine Allogeneic Prostate GVAX in Hormone-Refractory Prostate Cancer
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 a prime-boost dose schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine Allogeneic Prostate GVAX as measured by standard toxicity evaluation changes in PSA and tumor responses Additional objectives are to measure the time to PSA andor clinical disease progression as well as local and systemic immune responses to the vaccine
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