Flt3L in Treating Patients With Metastatic Colorectal Cancer

Phase 1

Completed

• Conditions: Colorectal Cancer; Metastatic Cancer

• Registration Number: NCT00003431
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 1998-06
• Study First Submitted: 1999-11-01
• Study Completion: 2001-05
• Study First Submitted QC: 2004-08-03
• Study First Posted: 2004-08-04
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-04
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States