Defibrotide in Treating Patients With Liver Damage Following Peripheral Stem Cell Transplantation

Veno-occlusive Disease Clinical Trial

Official title: Defibrotide for Hematopoietic Stem Cell Transplant Patients With Severe Hepatic Venocclusive Disease: A Phase I/II Study to Determine the Minimal Effective Dose

Status Completed

Clinical Trial Summary

RATIONALE: Giving defibrotide may be an effective treatment for liver damage that may result following peripheral stem cell transplantation.

PURPOSE: This randomized phase II trial is studying defibrotide to see how well it works in treating patients with severe liver disease after undergoing peripheral stem cell transplantation.

Clinical Trial Description

OBJECTIVES:

• Determine complete response rate in post-hematopoietic stem cell transplant patients with severe veno-occlusive disease of the liver treated with defibrotide.

• Determine the minimal effective dose of this drug in these patients.

• Assess toxicity and adverse side effects of this drug in these patients.

OUTLINE: This is a randomized, multicenter study. All patients initially receive the same dose of defibrotide IV over 2 hours every 6 hours on day 1. On day 2, patients are randomized to 1 of 2 doses of defibrotide.

• Arm I: On days 2-14, patients receive a lower dose of defibrotide IV over 2 hours every 6 hours.

• Arm II: On days 2-14, patients receive a higher dose of defibrotide IV over 2 hours every 6 hours.

In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 140 patients (70 per treatment arm) will be accrued for this study. ;

Related Conditions & MeSH terms

• Veno-occlusive Disease

• NCT number: NCT00003966
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Completed
• Phase: Phase 2
• Start date: April 2000
• Completion date: April 2006