Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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 directly to liver tumors and provide
a treatment to patients with liver cancer.
Patients enrolled in the study will be administered MTC-DOX through a hepatic artery catheter
inserted under radiological guidance. During and following injection of the MTC-DOX, the drug
will be localized to the hepatic tumor site by use of an external magnet. Dose may be divided
in order to localize MTC-DOX to all lesions. The MTC-DOX intrahepatic infusions will be
repeated every three weeks until tumor progression, complete remission, unacceptable
toxicity, or a maximum of six treatment cycles.
The purpose of this Phase 1/2 study is to evaluate time to disease progression following
administration of MTC-DOX.