Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Bladder

Inclusion Criteria

• •Histologically confirmed stage IV bladder carcinoma that is unlikely to respond to existing therapy and for which no curative therapy exists or stage IV newly diagnosed, incurable bladder carcinoma
• •Measurable disease by CT scan
• •Tumor must be greater than 2 cm at the largest diameter for the lymph nodes located in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in the largest diameter for other localizations
• •18 and over
• •Karnofsky 60-100%
• •Life expectancy: greater than 2 months
• •WBC at least 2,000/mm\^3
• •Platelet count at least 50,000/mm\^3
• •Bilirubin no greater than 2.5 mg/dL
• •SGOT/SGPT no greater than 5 times upper limit of normal
• •No hepatic failure
• •Creatinine no greater than 2.5 mg/dL
• •No history of renal conditions that contraindicate high dosages of sodium
• •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
• •No severe lung disease
• •Not pregnant or nursing
• •Fertile patients must use effective contraception during and for 4 weeks after study participation
• •No serious active infections or fever
• •No other serious concurrent disease
• •At least 4 weeks since prior immunotherapy and recovered
• •No concurrent immunomodulating agents
• •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
• •Concurrent corticosteroids allowed
• •At least 8 weeks since prior radiotherapy and recovered
• •Recovered from any prior operative procedure
• •Prior cytodifferentiating agent allowed