Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274287
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2006-01-06
Brief Title:
GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere
Sponsor:
Oncology Specialists SC
Organization:
Oncology Specialists SC
Study Overview
Official Title:
A Phase II Pilot Study Investigating the Efficacy and Activity of Single Agent GM-CSF Leukine Maintenance Approach in Androgen-independent Prostate Cancer AIPC Patients Responding to Taxotere Chemotherapy
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is designed to investigate the efficacy and safety of GM-CSF used as a maintenance program in patients with androgen-independent prostate cancer AIPC who have achieved a maximal response on a taxotere or other chemotherapy schedule
Detailed Description:
Patients will be treated on this single arm open label trial until primary end point is met patients withdrawal or investigators discretion After achieving a maximal response on taxotere or other chemo schedule they were eligible to enroll in this trial and begin treatment with maintenance GMCSF for 2 weeks followed by 2 weeks of rest Once progression was documented the patients were taken off study
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