Hepatic Arterial Infusion With Melphalan in Treating Patients With Unresectable Liver Cancer

Phase 1

Completed

• Conditions: Metastatic Cancer; Liver Cancer

• Registration Number: NCT00030082
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

RATIONALE: Heating melphalan to several degrees above body temperature and infusing it to the affected area directly around the tumor may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of hepatic arterial infusion with melphalan in treating patients who have unresectable liver cancer.

Detailed Description

OBJECTIVES:

* Determine the dose-limiting toxicity and maximum tolerated dose of hepatic arterial infusion with melphalan in patients with unresectable liver cancer.

* Determine the regional and systemic toxic effects of this drug in these patients.

* Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients undergo percutaneous hepatic arterial infusion, using a double balloon catheter in the inferior vena cava to isolate circulation to the liver, with melphalan over 30 minutes on day 1. Treatment may be repeated when all toxic effects are grade 2 or less. Patients undergo staging at 4 weeks after completion of the second treatment. Patients may receive 2 additional treatments.

Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are treated with melphalan at the recommended dose.

Patients are followed every 3 months for 2 years and then every 4 months for 1 year.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2002-01-30
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2004-07
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-04-30

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)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States