Perfusion-Induced Hyperthermia for Metastatic Carcinoma

Exclusion Criteria

• •Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C, or monoclonal antibodies such as bevacizumab, cetuximab or panitumumab) prior to entering the study or those who have not recovered to \< grade 2 adverse events due to agents administered more than 4 weeks earlier.
• •Patients with stroke or TIA within 90 days prior to enrollment; or peripheral vascular disease requiring intervention within the 90 days prior to enrollment; or any known hemodynamically significant lesion or embolic plaque.
• •Patients must have normal organ and marrow function as defined below:
• •* leukocytes ≥3,000/mcL
• •* absolute neutrophil count ≥1,500/mcL
• •* total Bilirubin, AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
• •* glomerular filtration rate (GFR)\> 60 as defined by the Modification of Diet in Renal Disease (MDRD) formula
• •* Thromboplastin Time (PTT) \< 35 sec)
• •Patients with uncontrolled seizure disorder, spinal cord compression or carcinomatous meningitis.
• •Patients with a mental disorder, psychiatric illness/social or concussion which would inhibit their ability to provide informed consent or prevent compliance with follow-up.
• •Patients with high risk of cardiovascular event such as severe uncontrolled hypertension (\>170/110 systemic blood pressure on therapy), or pulmonary hypertension (greater than .5 systolic blood pressure
• •ST elevation myocardial infarction within 30 days prior to enrollment; unstable angina or significant, untreated arrhythmias within 30 days prior to enrollment.
• •Patients with moderate to severe heart failure, New York Heart Association (NYHA) class III or IV, liver dysfunction with total bilirubin \>2. 5 upper limit of normal, or serum creatinine \>2.5 mg/dL or any form of dialysis; within 30 days prior to enrollment.
• •Patients with a major surgical procedure or other investigational agents within 30 days before study enrollment.
• •Patients with known, untreated or progressive brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• •Pregnant women are excluded from this study
• •Patients with documented contraindication to anticoagulation therapy such as heparin induced thrombocytopenia or a documented coagulopathy or hematologic disorder that would contraindicated undergoing treatment and use of the associated anticoagulant agents required during treatment.
• •Patients with documented active bacterial, viral or fungal infection, untreated systematic peptic ulcer disease, uncontrolled diabetes mellitus or serious concurrent medical disease that could limit survival to less than 3 months.
• •HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for harm when exposed to hyperthermia, as well as negative interactions of these medications with hyperthermia.