Flt3L in Treating Patients With Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00003431|
Recruitment Status : Completed
First Posted : August 4, 2004
Last Update Posted : March 5, 2013
RATIONALE: Flt3L may stimulate a person's 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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic Cancer||Biological: recombinant flt3 ligand||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Pilot Study of FLT3 Ligand Prior to Resection of Hepatic Metastases of Colorectal Cancer|
|Study Start Date :||June 1998|
|Actual Study Completion Date :||May 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003431
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Michael A. Morse, MD||Duke Cancer Institute|