Magnetic-Targeted Doxorubicin in Treating Patients With Cancer Metastatic to the Liver
Metastases, Neoplasm, Colorectal Neoplasms, Esophageal Neoplasms
About this trial
This is an interventional treatment trial for Metastases, Neoplasm focused on measuring Metastatic liver cancer, Cholangiocarcinoma, colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, breast cancer, malignant melanoma, sarcoma, GIST, gastrointestinal stromal tumor, lung cancer, liver cancer
Eligibility 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.
Sites / Locations
- Scripps Stevens Cancer Division
- UCSF Cancer Center
- Scott and White Clinic
- Frankfurt Universtiy