Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads Vs. IV Doxorubicin in Treating Liver Cancer
Stopped early · Phase 2/Phase 3
Conditions studied: Carcinoma, Hepatocellular
In brief
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. To be sure of the effect of MTC-DOX on liver cancer, it will be compared to the effect of Doxorubicin given through the vein. The study treatments will be administered every three weeks, (which is considered a study treatment cycle), until you complete six treatment cycles, the tumor grows, disappears, or you experience a side effect, which may cause you to leave the study. Follow-up visits will occur on Days 3, 10, and 21 following treatment in the first cycle and Days 7 and 21 for the remaining cycles, and also 60 days after you receive your last treatment cycle. Therefore, the purpose of this Phase 2/3 study is to evaluate safety, tolerance, and efficacy (survival time) of an MTC-DOX dosing strategy where the DOX dose is determined by tumor size
Key facts
- Study ID
- NCT00034333
- Run by
- FeRx
- People needed
- 240
- Starts
- 2002-03-01
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Long Beach VA Medical Center — Long Beach, California, United States
- VAMC San Francisco and Comprehensive Cancer Ctr. — San Francisco, California, United States
- Northwestern Univ. Med. School — Chicago, Illinois, United States
- Weill Medical College of Cornell University — New York, New York, United States
- Univ. of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Allegheny-Singer Research Institute — Pittsburgh, Pennsylvania, United States
- University of Texas Medical Branch — Galveston, Texas, United States
- Scott & White Mem. Hosp. & Clinic — Temple, Texas, United States
- McGuire DVAMC — Richmond, Virginia, United States
- Landeskrankenhaus Graz University Hospital — Graz, Austria
- University Hospital Vienna — Vienna, Austria
- University Hospital Cologne — Cologne, Germany
- University Hospital Am Main — Frankfurt, Germany
- Queen Mary Hospital, University of Hong Kong — Pokfulam, Hong Kong
- Chinese Universtiy of Hong Kong — Shatin, N.T., Hong Kong
- Central Research Institute of Roentgenology and Radiology — Pesochny, Sankt-Peterburg, Russia
- N.N. Blokhin Cancer Research Center RAMS — Moscow, Russia
- Chulalongkorn University Hospital — Bangkok, Thailand
- Siriraj Hospital, Mahidol University — Bangkok, Thailand
- National Cancer Institute — Bangkok, Thailand
- Chiang Mai University — Chiang Mai, Thailand
- Khon Kaen Universtiy — Khon Kaen, Thailand
- Institute of Oncology AMS of Ukraine — Kiev, Ukraine
Full record on ClinicalTrials.gov
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