Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Mesothelioma

Fecha de inicio: 8 de marzo de 1996

DISEASE CHARACTERISTICS: Histologically confirmed stage IV mesothelioma that is unlikely to respond to existing therapy and for which no curative therapy exists Evidence of disease by CT scan or MRI PATIENT CHARACTERISTICS: Age: 1 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 2,000/mm^3 Platelet count at least 50,000/mm^3 Hepatic: Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal Hepatic function adequate Renal: Creatinine no greater than 2.5 mg/dL No renal insufficiency No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: No uncontrolled hypertension No history of congestive heart failure No cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No serious lung disease (e.g., chronic obstructive pulmonary disease) Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study participation Not at high medical or psychiatric risk No nonmalignant systemic disease No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent immunomodulatory agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: At least 8 weeks since prior radiotherapy (or less if multiple tumors) and recovered Surgery: Recovered from prior surgery Other: Prior cytodifferentiating agents allowed No prior antineoplastons No other concurrent antineoplastic agents