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

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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 MRI or 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

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 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

Other:

- 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

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

Endocrine therapy:

- Concurrent corticosteroids allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered

Surgery:

- Recovered from any prior operative procedure

Other:

- No prior antineoplaston therapy

- Prior cytodifferentiating agent allowed