Antineoplaston Therapy in Treating Patients With Recurrent or Extensive-Stage Small Cell Lung Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed recurrent or extensive stage small cell lung cancer unlikely to have a curative response to existing standard regimens
• •Measurable disease by MRI or CT scan
• •* At least 2 cm in diameter
• •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:
• •Bilirubin no greater than 2.5 mg/dL
• •SGOT/SGPT no greater than 5 times upper limit of normal
• •No hepatic failure
• •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 severe heart disease
• •No uncontrolled hypertension
• •No history of congestive heart failure
• •No history of other cardiovascular conditions that contraindicate high dosages of sodium
• •Pulmonary:
• •No severe 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
• •No active infections
• •No other concurrent serious disease
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •At least 4 weeks since prior immunotherapy and recovered
• •No concurrent immunomodulating agents
• •Chemotherapy:
• •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
• •No concurrent antineoplastic agents
• •Endocrine therapy:
• •Concurrent corticosteroids allowed
• •Radiotherapy:
• •At least 8 weeks since prior radiotherapy and recovered
• •Surgery:
• •Recovered from prior surgery
• •Other:
• •No prior antineoplaston therapy
• •Prior cytodifferentiating agent allowed