Spots Global Cancer Trial Database for Flt3L in Treating Patients With Metastatic Colorectal Cancer

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Trial Identification

Brief Title: Flt3L in Treating Patients With Metastatic Colorectal Cancer

Official Title: Pilot Study of FLT3 Ligand Prior to Resection of Hepatic Metastases of Colorectal Cancer

Study ID: NCT00003431

Conditions

Colorectal Cancer

Metastatic Cancer

Interventions

recombinant flt3 ligand

Study Description

Brief Summary: 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.

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.