NCT00041808

Magnetic-Targeted Doxorubicin in Treating Patients With Cancer Metastatic to the Liver

A Phase I/II Single Dose Trial to Determine The Safety, Tolerance, Pharmacokinetic Profile, and Preliminary Activity of Intrahepatic Delivery (Via Hepatic Artery Catheterization) of Doxorubicin Hydrochloride Adsorbed to Magnetic Targeted Carriers ( MTC-DOX) in Patients With Metastatic Cancer to the Liver .

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: FeRx · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to "stick", to magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and deposited in the area of a tumor, where it is thought that it then "leaks" through the blood vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes "free from" the magnetic beads and will then be able to act against the tumor cells. The iron component of the particle has magnetic properties, making it possible to direct MTC-DOX to specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that MTC-DOX used with the magnet may target the chemotherapy drug directly to liver tumors and provide a treatment to patients with cancers that have spread to the liver.

Conditions

• Metastases, Neoplasm
• Colorectal Neoplasms
• Esophageal Neoplasms
• Stomach Neoplasms
• Pancreatic Neoplasms
• Breast Neoplasms
• Melanoma
• Sarcoma
• Gastrointestinal Neoplasms
• Lung Neoplasms
• Liver Neoplasms
• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	MTC-DOX for Injection
PROCEDURE	Chemotherapy

Timeline

• Start date: 2001-07-01
• Completion: 2003-04-01
• First posted: 2002-07-19
• Last updated: 2005-06-24

Locations

4 sites across 2 countries: United States, Germany