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

Phase 2

Completed

• Conditions: Cancer
• Interventions: Drug: isolated perfusion; Drug: melphalan

• Registration Number: NCT00096083
• Lead Sponsor: Delcath Systems Inc.

Brief Summary

RATIONALE: Hepatic arterial infusion uses a catheter to deliver anticancer substances directly into the liver. Drugs used in chemotherapy, such as melphalan, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving an hepatic arterial infusion of melphalan together with hepatic perfusion works in treating patients with unresectable liver cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the response rate and duration of response in patients with unresectable primary or metastatic liver cancer treated with intrahepatic arterial infusion of melphalan with venous filtration via peripheral hepatic perfusion.

Secondary

* Determine the patterns of recurrence in patients treated with this regimen.

* Determine progression-free and overall survival of patients treated with this regimen.

* Evaluate the safety and tolerability of this regimen in these patients.

* Assess the filter characteristics including melphalan pharmacokinetics and filtration of cytokines and clotting factors during and after treatment.

OUTLINE: Patients are stratified according to primary tumor histology (neuroendocrine tumor vs primary hepatic malignancy vs adenocarcinoma of gastrointestinal or other origin).

Patients undergo peripheral isolated hepatic perfusion in which a catheter is placed via the groin into the hepatic artery and another into the hepatic vein. Patients then receive melphalan as an intrahepatic arterial infusion over 15-30 minutes. Treatment repeats approximately every 3-8 weeks for up to 6 total infusions in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study within 4-5 years.

Study Timeline

• Study Start: 2004-09
• Study First Submitted QC: 2004-11-08
• Study First Submitted: 2004-11-09
• Study First Posted: 2004-11-09
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-22
• Last Update Posted: 2013-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Melphalan Administration PHP	isolated perfusion	-
Melphalan Administration PHP	melphalan	-

Primary Outcome Measures

Name	Time	Method
To determine the response rate and duration of response to intra-hepatic infusion of melphalan with subsequent venous hemofiltration in patients with primary and metastatic hepatic malignancies	Survivial

Secondary Outcome Measures

Name	Time	Method
To determine the patterns of recurrence following percutaneous hepatic perfusions (PHP) with melphalan	Survival
To determine the progression free and overall survival in patients with hepatic malignancies following this therapy	Survivial

Trial Locations

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office; 🇺🇸 Bethesda, Maryland, United States