NCT00001587

A Phase I Study of Isolated Hepatic Portal and Arterial Perfusion (IHP) With Escalating Dose Melphalan for Primary or Metastatic Unresectable Cancers of the Liver

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Patients with unresectable primary or metastatic cancer confined to the liver will undergo a 1 hour hyperthermic isolated hepatic perfusion (IHP) via the portal vein and hepatic artery with escalating dose melphalan. Patients eligible for this protocol are those with non-colorectal histologies and those with colorectal cancer previously treated with intra-arterial FUDR. Hepatic and systemic toxicity, response to treatment, duration of response, and survival will be followed.

Detailed description

Patients with unresectable primary or metastatic cancer confined to the liver will undergo a 1 hour hyperthermic isolated hepatic perfusion (IHP) via the portal vein and hepatic artery with escalating dose melphalan. Patients eligible for this protocol are those with non-colorectal histologies and those with colorectal cancer previously treated with intra-arterial FUDR. Hepatic and systemic toxicity, response to treatment, duration of response, and survival will be followed.

Conditions

• Liver Neoplasms
• Neoplasm Metastasis

Interventions

Type	Name	Description
PROCEDURE	Isolated hepatic portal and arterial perfusion
DRUG	Melphalan

Timeline

• Start date: 1997-09-01
• Completion: 2001-03-01
• First posted: 2002-12-10
• Last updated: 2008-03-04

Locations

1 site across 1 country: United States