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

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

Current therapies for Stage IV bladder cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV bladder cancer

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV bladder cancer.

Stage IV bladder cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

• To determine the efficacy of Antineoplaston therapy in patients with Stage IV bladder cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
• To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV bladder cancer.
• To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

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

Exclusion Criteria:

- Prior antineoplaston therapy