Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II, Open Label, Multicenter, Single-Arm, Safety and Efficacy Study of Doxorubicin Hydrochloride Adsorbed to Magnetic Targeted Carriers (MTC-DOX) Administered by Intrahepatic Delivery (Via Hepatic Artery Catheterization) for the Treatment of Patients With Unresectable Hepatocellular Carcinoma.|
|Cancer Institute & Hosp. CAMS|
|Chinese PLA Cancer Ctr. Yang Gongjing|
|Nanjing City, China|
|Zhong Shan Hospital, Fudan University|
|Study Director:||Joy Koda, Ph. D.||VP Clinical Development|