Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054951
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-02-13
Brief Title:
Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads
Sponsor:
FeRx
Organization:
FeRx
Study Overview
Official Title:
A Phase III 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
Status:
UNKNOWN
Status Verified Date:
2003-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 12 study is to evaluate time to disease progression following administration of MTC-DOX
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 12 study is to evaluate time to disease progression following administration of MTC-DOX
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None