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Home > "S" Clinical Trials Conditions > Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads vs. IV Doxorubicin in Treating Liver Cancer  Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads vs. IV Doxorubicin in Treating Liver Cancer
Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads vs. IV Doxorubicin in Treating Liver Cancer
For Condition: Carcinoma, Hepatocellular
Status: Terminated
Sponsor(s): FeRx ,
Synopsis: 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
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: Patients may be enrolled into this protocol only if all of the following inclusion criteria are met: - Unresectable hepatocellular carcinoma diagnosed by CT scan and meets the criteria described in Section 23. - Total combined cross-sectional area of all hepatic tumors as determined by CT scan is between 4 and 200 cm2. - Center of the tumor(s) mass must be 60 and an estimated life expectancy of > 3 months. - Is judged by the investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to allow follow-up. - Have the ability to give informed written consent prior to initiation of therapy. - If female and of childbearing potential,must have a negative beta-HCG prior to receiving treatment. - Must agree to use an effective method of contraception Patients will be excluded from enrollment if any of the following apply: - Has a history of cancer other than hepatocellular (excluding resected basal cell carcinoma; or curatively resected stage 1 or less cervical cancer if disease free for 5 years or more). - Has had prior local radiation therapy within the last 4 weeks, mediastinal radiation therapy within the last 3 months, or chemotherapy within the last 4 weeks. - Diffuse hepatocellular carcinoma or disease that precludes delivery of the drug to the tumor via a vessel that feeds the tumor. - Has another active medical condition(s) or organ disease(s) that may either compromise patient safety or interfere with the safety and/or outcome (e.g., survival) evaluation of the study drugs. While this exclusion is not limited to the following abnormalities, if any of the following laboratory abnormalities are present, the patient should be excluded: WBC < 2,000 /uL Platelets < 50,000/uL Hemoglobin < 8.0 gm/dL Total bilirubin > 3.0 mg/dL ALT or AST >/= 5 x upper limit of normal Serum Creatinine >2.0 mg/dL INR >/= 1.5 - Has cardiac dysfunction with a left ventricular ejection fraction < 40%. - Has clinically significant pulmonary impairment - Plans concomitant chemotherapy, radiation therapy, hormonal and/or biological treatment for cancer including immunotherapy while on study. - Has an indwelling cardiac pacemaker, cerebral aneurysm clips, or any other indwelling device or appliance that could be adversely affected by the use of the external magnet. - Has documented evidence of hemachromatosis or hemosiderosis. - Has CT or ultrasound evidence of portal vein invasion or thrombosis. - Prior orthotopic hepatic transplant. - Has received previous treatment with doxorubicin, idarubicin, and/or other anthracyclines or anthracenes. - Has a known allergy to doxorubicin, MTC-DOX or any of their components. - Has been treated with any investigational drug, investigational biologic, or investigational therapeutic device within 30 days of initiating study treatment.
Total Enrollment: 240
Location and Contact Information:
Overall Study Official:
JoyKoda, Study Chair, FeRx
Northwestern Univ. Med. School
Chicago, Illinois, 60611
United States
University Hospital Am Main
Frankfurt, ,
Germany
Landeskrankenhaus Graz University Hospital
Graz, ,
Austria
Scott & White Mem. Hosp. & Clinic
Temple, Texas, 76508
United States
Chiang Mai University
Chiang Mai, ,
Thailand
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Univ. of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Institute of Oncology AMS of Ukraine
Kiev, , 03022
Ukraine
McGuire DVAMC
Richmond, Virginia, 23249
United States
Chulalongkorn University Hospital
Bangkok, , 10330
Thailand
Edinburgh Royal Infirmary
Edinburgh, Scotland,
United Kingdom
N.N. Blokhin Cancer Research Center RAMS
Moscow, , 115478
Russian Federation
VAMC San Francisco and Comprehensive Cancer Ctr.
San Francisco, California, 94121
United States
University Hospital Vienna
Vienna, ,
Austria
Leicester Royal Infirmary
Leicester, England,
United Kingdom
Central Research Institute of Roentgenology and Radiology
Pesochny, St. Petersburg, 197758
Russian Federation
Siriraj Hospital, Mahidol University
Bangkok, , 10700
Thailand
Long Beach VA Medical Center
Long Beach, California, 90822
United States
University Hospital Cologne
Cologne, , 50924
Germany
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212
United States
Queen Mary Hospital, University of Hong Kong
Pokfulam, ,
Hong Kong
Khon Kaen Universtiy
Khon Kaen, , 40002
Thailand
Queen Elizabeth Hospital
Edgbaston, Birmingham, B152TH
United Kingdom
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
National Cancer Institute
Bangkok, ,
Thailand
Chinese Universtiy of Hong Kong
Shatin, N.T., ,
Hong Kong
Weill Medical College of Cornell University
New York City, New York, 10021
United States
University of Texas Medical Branch
Galveston, Texas, 77555
United States
St. George's Hospital
London, England,
United Kingdom
Additional Information:
Study ID Numbers: MTC-DOX-004;
Study Start Date: March 2002
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034333
Other Carcinoma, Hepatocellular Studies:
1. A Study to Estimate Safety and Efficacy of Bay 43-9006 in the Treatment of Hepatocellular Carcinoma
2. A phase II multicenter uncontrolled trial of BAY 43-9006 in patients with advanced hepatocellular carcinoma
3. A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure
4. Testing of ADI-PEG in Hepatocellular Carcinoma
5. Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
Related Studies:
Other Carcinoma, Hepatocellular Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads vs. IV Doxorubicin in Treating Liver Cancer
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