Phase II Study of Antineoplastons A10 and AS2-1 Capsules In Patients With Non Small Cell Lung Cancer

Fecha de inicio: 21 de agosto de 1996

DISEASE CHARACTERISTICS: Histologically confirmed stage IV non-small cell lung cancer that cannot be cured with existing therapeutic regimens Measurable disease by CT scan or MRI Tumor must be at least 2 cm for the lymph nodes located in the head, neck, axillary, inguinal or femoral areas and at least 0.5 cm for other areas PATIENT CHARACTERISTICS: Age: 18 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: No hepatic insufficiency Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal Renal: No renal insufficiency Creatinine no greater than 2.5 mg/dL Cardiovascular: No chronic heart failure No uncontrolled hypertension Pulmonary: No serious lung disease (e.g., severe chronic obstructive pulmonary disease) Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study participation No other serious medical or psychiatric conditions No active infection No serious malabsorption syndromes PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered 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 (less than 8 weeks if multiple tumors are involved) and recovered Surgery: No prior extensive stomach or intestinal surgery Recovered from any prior surgery Other: Prior cytodifferentiating agents allowed No prior antineoplaston treatment No other concurrent treatment for metastatic lung cancer