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Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver Clinical research trials and Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver  Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
For Condition: Sarcoma,Cholangiocarcinoma,Stomach Neoplasms,Lung Neoplasms,Melanoma,Esophageal Neoplasms,Metastases, Neoplasm,Breast Neoplasms,Pancreatic Neoplasms,Gastrointestinal Neoplasms,Colorectal Neoplasms,Liver Neoplasms
Status: Completed
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 drug directly to liver tumors and provide a treatment to patients with cancers that have spread to the liver.
Details:
Eligibility:
Study Type: Interventional,Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Patients with a Karnofsky (or equivalent) performance status > 60 and an expected survival of > 2 months - Patients agreeing to use a medically effective method of contraception - Patients able to understand and give written informed consent - The center of the tumor mass must be < or = 14 cm from the anterior or lateral abdominal wall as determined by cross sectional imaging measured at baseline. This is required for optimal retention of MTC-DOX by the magnetic field. If more than one tumor mass is present, all of the treated tumor masses must meet this criterion Exclusion Criteria - Women who are pregnant or lactating - Patient’s with metastatic liver cancer, or other primary liver cancer excluding HCC, with diffuse disease that does not have focal area(s) conducive to local regional therapy - Patients with the following laboratory abnormalities:Hemoglobin < 10.0 g/dL;Granulocyte count < 1,500 per mm3;Platelet count < 50,000 per mm3; Lymphocyte count < 0.5 x 10 to the 9th per L; Total bilirubin >/= 3.0 mg/dL;AST or ALT >/= 5x the upper limit of normal;INR >/= 1.3; Creatinine >/= 2.0 mg/dL - Patients with either significant cardiovascular disease or any other organ system dysfunction which, in the opinion of the investigator, would either compromise the patient's safety or interfere with the evaluation of the test material. Patients with evidence of a myocardial infarction within six (6) months prior to this trial will be excluded. - Patients with 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 - Patients at the time of study entry with a second invasive cancer other than basal cell and squamous cell carcinoma of the skin, or carcinoma in situ of the cervix - Patients with documented evidence of hemachromatosis or hemosiderosis - Patients with CT or ultrasound evidence of portal vein invasion or thrombosis - Patients who have had prior anthracycline therapy with a left ventricular ejection fraction (LVEF) <50%, as measured by either multigated radionuclide angiography (MUGA) scan or echocardiogram.
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
JoyKoda, Study Chair,
Scott and White Clinic
Temple, Texas, 76508
United States
Frankfurt Universtiy
Frankfurt, , 60590
Germany
Scripps Stevens Cancer Division
San Diego, California, 92037
United States
UCSF Cancer Center
San Francisco, California, 94143
United States
Additional Information:
Study ID Numbers: MTC-DOX-003;
Study Start Date: July 2001
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041808
Other Melanoma Studies:
1. Study of T900607-sodium in subjects with previously treated gastric cancer or adenocarcinoma of the esophagus
2. Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer
3. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
4. A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Solid Malignancies
Related Studies:
Other Melanoma Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
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