Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
Condition: Liver Cancer; Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Liver Neoplasms
Intervention: computed tomography; magnetic resonance imaging; positron emission tomography; radiofrequency ablation; radionuclide imaging; ultrasound imaging; fludeoxyglucose F 18 (FDG-PET); gadopentetate dimeglumine
Intervention description: Scan to assess the effects of ablation.; Imaging used to assess the effects of this ablative therapy on tumor vascular density.; Physiology based method of imaging disease based on uptake and metabolism of radiopharmaceutical by the tissues.; Radiofrequency ablation uses saline infusion into and out of needle/electrode through a closed system. More energy may be deposited without tissue-charring or gas vaporization.; Imaging following injection of a radioactive material.; An ultrasound (e.g. sound waves) is used to identify the lesion and needle placement.; FDG PET scans rely on metabolic changes to evaluate response to therapy.; Food and Drug Administration approved contrast agent.
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: localized unresectable adult primary liver cancer; recurrent adult primary liver cancer; liver metastases; unspecified adult solid tumor, protocol specific

Summary:

      RATIONALE: Radiofrequency ablation is a procedure that heats tumors to several degrees above
      body temperature and may kill tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating
      patients who have unresectable primary or metastatic liver cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary or metastatic liver lesions

               -  Not a candidate for surgical resection

          -  Must have six or fewer lesions and no single lesion greater than 7 cm in diameter

          -  Extrahepatic disease allowed

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Eastern Cooperative Oncology Group (ECOG) 0-2

        Life expectancy:

          -  At least 3 months

        Hematopoietic:

          -  Platelet count at least 50,000/mm^3

          -  Prothrombin time (PT) or partial thromboplastin time (PTT) no greater than 1.5 times
             control (except for therapeutically anticoagulated nonrelated medical conditions
             [e.g., atrial fibrillation])

        Hepatic:

          -  Bilirubin no greater than 3.0 mg/dL

        Renal:

          -  Creatinine no greater than 2.5 mg/dL

        Other:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  No pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic
             devices

          -  No known uncontrollable serious reactions (e.g., anaphylaxis) to contrast agents used
             in this study

          -  Weight less than 136 kg

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  Not specified

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  Not specified

        Surgery:

          -  Not specified

        Other:

          -  Concurrent systemic therapy for extrahepatic disease is allowed only if begun prior to
             radiofrequency ablation