Heat Activated Liposomal Doxorubicin and Radiofrequency Ablation in Treating Patients With Primary or Metastatic Liver Tumors
Liver Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring advanced adult primary liver cancer, liver metastases, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed tumor of the liver Primary or metastatic disease No more than 4 lesions No single lesion > 7 cm in maximum diameter Not a candidate for curative surgical resection due to tumor histology or prior surgery PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic Platelet count ≥ 75,000/mm^3 WBC ≥ 1,500/mm^3 Hemoglobin ≥ 10 g/dL (transfusions to attain levels ≥ 10g/dL allowed) Hepatic Bilirubin ≤ 2.0 mg/dL PT or PTT ≤ 1.5 times control (except for patients receiving anticoagulation therapy for an unrelated medical condition [e.g., atrial fibrillation]) Renal Creatinine ≤ 2.5 mg/dL Cardiovascular See Hepatic Ejection fraction ≥ 50% by MUGA No congestive heart failure No myocardial infarction within the past 6 months No cerebral vascular accident within the past 6 months No life-threatening cardiac arrhythmia Other Weight < 136 kg Glucose ≤ 300 mg/dL No uncontrolled diabetes No known serious uncontrolled reaction (e.g., anaphylaxis) to contrast agents used in this study No known allergy to egg or egg products No other serious medical illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent interferon No live vaccines (for immunosuppressed patients only) during and for 30 days after study treatment Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery See Disease Characteristics Other More than 3 weeks since prior therapy for liver tumor(s) More than 3 weeks since prior systemic therapy for non-life-threatening extrahepatic disease and recovered No other concurrent systemic therapy No administration of any of the following medications during and for 30 days after study treatment: Cyclosporine Phenobarbital Phenytoin Streptozocin No concurrent administration of any of the following medications: Amphotericin B by injection Antithyroid agents for overactive thyroid Azathioprine Chloramphenicol Colchicine Flucytosine Ganciclovir Plicamycin Zidovudine Probenecid Sulfinpyrazone
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
- Queen Mary Hospital - Hong Kong