Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003431
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
1999-11-01
Brief Title:
Flt3L in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Pilot Study of FLT3 Ligand Prior to Resection of Hepatic Metastases of Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-03
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:
RATIONALE Flt3L may stimulate a persons immune system and help kill tumor cells
PURPOSE Phase I trial to study the effectiveness of flt3L given to patients before undergoing surgery to remove metastases from colorectal cancer
PURPOSE Phase I trial to study the effectiveness of flt3L given to patients before undergoing surgery to remove metastases from colorectal cancer
Detailed Description:
OBJECTIVES I Evaluate the safety and feasibility of administering flt3 ligand to patients with hepatic metastases from colorectal cancer prior to surgical resection
OUTLINE Patients receive flt3 ligand subcutaneously for 14 days followed by 14 days of rest This course of therapy may be repeated for a total of 3 courses Leukapheresis is performed on day 15 of the last course of Flt3 ligand Patients undergo restaging and metastasis resection Patients are followed every 3 months for the first year every 6 months for the second year and yearly thereafter
PROJECTED ACCRUAL This study will accrue 12 patients in 1 year
OUTLINE Patients receive flt3 ligand subcutaneously for 14 days followed by 14 days of rest This course of therapy may be repeated for a total of 3 courses Leukapheresis is performed on day 15 of the last course of Flt3 ligand Patients undergo restaging and metastasis resection Patients are followed every 3 months for the first year every 6 months for the second year and yearly thereafter
PROJECTED ACCRUAL This study will accrue 12 patients in 1 year
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 |
|---|---|---|---|
| DUMC-98032 | None | None | None |
| NCI-G98-1454 | None | None | None |