Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00400517
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2006-11-16
Brief Title:
GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Phase II Trial of Neoadjuvant GM-CSF Thalidomide in High-Risk Patients With Prostate Cancer Undergoing Prostatectomy
Status:
COMPLETED
Status Verified Date:
2018-07
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:
RATIONALE Biological therapies such as GM-CSF may stimulate the immune system in different ways and stop tumor cells from growing Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer
PURPOSE This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer
Detailed Description:
OBJECTIVES
Evaluate the impact of neoadjuvant sargramostim GM-CSF and thalidomide on pathologic response histologic P0 margin positivity capsular penetration prostate-specific antigen PSA response and other investigational endpoints in patients with high-risk prostate cancer undergoing prostatectomy
Determine the safety and feasibility of GM-CSF and thalidomide
OUTLINE This is an open-label study
Patients receive sargramostim GM-CSF subcutaneously on days 1 3 and 5 and oral thalidomide on days 1-5 or 1-7 in weeks 1-4 Treatment repeats every 4 weeks for 2 courses in the absence of unacceptable toxicity
Patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy at week 8 or 9
PROJECTED ACCRUAL A total of 29 patients will be accrued for this study
Evaluate the impact of neoadjuvant sargramostim GM-CSF and thalidomide on pathologic response histologic P0 margin positivity capsular penetration prostate-specific antigen PSA response and other investigational endpoints in patients with high-risk prostate cancer undergoing prostatectomy
Determine the safety and feasibility of GM-CSF and thalidomide
OUTLINE This is an open-label study
Patients receive sargramostim GM-CSF subcutaneously on days 1 3 and 5 and oral thalidomide on days 1-5 or 1-7 in weeks 1-4 Treatment repeats every 4 weeks for 2 courses in the absence of unacceptable toxicity
Patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy at week 8 or 9
PROJECTED ACCRUAL A total of 29 patients will be accrued for this 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE-CCF-4643 | OTHER | None | None |
| CELGENE-CASE-CCF-4643 | OTHER | None | None |
| BRLX-CASE-CCF-4643 | OTHER | Sponsor | httpsreporternihgovquickSearchP30CA043703 |