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Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma

NCT00324727 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2021-06-21

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving melphalan directly into the arteries around the tumor may kill more tumor cells. It is not yet known whether hepatic arterial infusion with melphalan is more effective than standard therapy in treating liver metastases due to melanoma.

PURPOSE: This randomized phase III trial is studying hepatic arterial infusion with melphalan to see how well it works compared to standard therapy in treating patients with unresectable liver metastases due to melanoma.

Conditions

Interventions

DRUG

melphalan

Given throug isolated hepatic artery infusion

DRUG

regional chemotherapy

Patients receive the best alternative therapy

DRUG

systemic chemotherapy

Patients receive the best alternative therapy

PROCEDURE

hepatic artery embolization

Patients receive the best alternative therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Delcath Systems Inc.

    lead INDUSTRY

Principal Investigators

  • Marybeth S. Hughes, MD · NCI - Surgery Branch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00324727 on ClinicalTrials.gov