Phase II Evaluation of IV Melphalan (L-PAM) and Whole Body Hyperthermia (WBH) for Malignant Melanoma

Date de début de l'étude : 1 décembre 1995

DISEASE CHARACTERISTICS: Histologically confirmed advanced melanoma beyond hope of surgical cure or metastatic disease Tumors must be refractory to all known forms of effective therapy No CNS tumor involvement No major liver involvement (more than 33% replacement of liver by tumor) PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC greater than 3,000/mm3 Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Alkaline phosphatase no greater than 3 times normal SGOT no greater than 3 times normal Protein no less than 15% below lower limit of normal Renal: BUN less than 30 mg/dL Creatinine less than 1.5 mg/dL OR Creatinine clearance no less than 60 mL/min Calcium no greater than 11.0 mg/dL Sodium 130-150 mEq/L Potassium 3.0-5.0 mg/dL Cardiovascular: No organic heart disease, including: - coronary artery disease - history of angina - history of dysrhythmia requiring ongoing medical intervention - uncontrolled hypertension - patients requiring beta blockers Neurologic: No moderate or severe peripheral neuropathy No history of severe emotional instability by psychiatric history Pulmonary: FEV1 at least 60% of predicted Maximum voluntary volume at least 60% of predicted Partial pressure of oxygen at least 60 OR Oxygen saturation at least 90% Other: No history of secondary primary cancer which conceivably could be active No active nonmalignant gastric and/or duodenal ulcer No serious infection requiring hospitalization within the previous 14 days No history of hepatitis related to general anesthesia No history of allergy to lidocaine or related compounds No development of malignant hyperthermia after general anesthesia No unexplained persistent fever Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since biologic therapy Chemotherapy: At least 8 weeks since nitrosoureas (e.g., lomustine, carmustine, mitomycin) At least 4 weeks since any other chemotherapy Recovered from all toxic effects No concurrent chemotherapy Endocrine therapy: At least 4 weeks since endocrine therapy No concurrent hormonal therapy Radiotherapy: At least 4 weeks since radiotherapy No prior irradiation of more than 25% of the marrow Surgery: Not specified Other: No concurrent nonsteroidal antiinflammatory agents or aspirin