Trial Information

Summary: Phase II Study Of Antineoplastons A10 And AS2-1 In Children With Hepatoblastoma

Demonstrate the antitumor activity of Antineoplaston A10 and AS2-1 in the treatment of children with hepatoblastoma by determining the proportion of patients who experience an objective tumor response.

Evaluate the adverse affect and tolerance of Antineoplaston A10 and AS2-1 in these patients.

Inclusion Criteria:

• Children less than 18 years and more than 6 months of age with a diagnosis of incurable hepatoblastoma in whom the disease has recurred or progressed, or who have residual tumor following standard therapy, and who have failed to respond to surgical (if appropriate) and standard chemotherapy regimen.
• Patients must have evidence of hepatoblastoma by gadolinium- enhanced MRI, or contrast-enhanced CT scan performed within two weeks prior to entry. There will be no exclusion based on tumor size, multifocality, or systemic metastases.
• Patients must have a performance status of 60% to 100% on the Karnofsky Performance Scale (Appendix C). Patients must have no evidence of hepatic insufficiency, total bilirubin below 0.5 mg/dL, and SGOT and SGPT not higher than five times the upper limit.
• Patients must have a relatively normal hematologic, hepatic and renal function- serum creatinine concentration not higher than 2.5 mg/dL, WBC > 2,000/mm3, and platelets > 50,000/mm3.
• Patients may be male or female. If female is of childbearing age, the patient must not be pregnant or breast-feeding an infant, and either incapable of becoming pregnant or currently using contraceptives. Acceptable methods include the birth control pill, use of a diaphragm, intrauterine device, or condom by the patient's sexual partner. If the male is of a sexually active age, the patient should use appropriate contraception, such as condoms during the study and at least 4 weeks following completion of the study.
• Patients should be outpatients, but must have a life expectancy of at least two months with the feasibility of doing a complete follow-up.
• The use of corticosteroids is permitted to reduce symptoms and signs attributed to cerebral edema. It is recommended that the smallest dose be used which is compatible with the preservation of optimal function. Corticosteroids should be carefully monitored and recorded.
• Patients must recover from the adverse effect of previous therapy. At least eight weeks must have relapsed since the last dose of radiation therapy and at least four weeks must have relapsed since the last dose of chemotherapy (six weeks for nitrosoureas) or immunotherapy.
• The patients with hypertension, history of congestive heart failure, or history of cardiovascular or renal conditions that medically contraindicate administration of high dosages of sodium are not to be enrolled on treatment.

EXCLUSION CRITERIA:

• Patients should not have serious active infections, fever, or other serious concomitant disease that would interfere with the evaluation of treatment drug (e.g., severe heart or lung disease, or hepatic failure).
• Patients with hypertension are excluded unless the blood pressure is adequately controlled.
• Patients who have had prior Antineoplaston treatment should be excluded from this protocol.

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