Flt3L in Treating Patients With Metastatic Colorectal Cancer
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.
Biological: recombinant flt3 ligand
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Pilot Study of FLT3 Ligand Prior to Resection of Hepatic Metastases of Colorectal Cancer|
|Study Start Date:||June 1998|
|Study Completion Date:||May 2001|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003431
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Michael A. Morse, MD||Duke Cancer Institute|