Antineoplaston Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

Inclusion Criteria

• •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