Trial Information

Summary: A phase II study of Antineoplastons A10 And AS2-1 Children With Visual Pathway Glioma

To demonstrate the antitumor activity of Antineoplaston A10 and AS2-1 in the treatment of children with visual pathway glioma by determining the proportion of patients who experience an objective tumor responses. To evaluate the adverse effects 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 visual pathway glioma who are unlikely to respond to existing therapeutic regimens and for whom curative therapeutic regimens do not exist.
• The patient should have histological confirmation of the brain tumor under study (either at the initial diagnosis or at the recurrence); the only exceptions are some cases of dangerous locations of brain tumors such as brain stem tumors, where biopsy may entail unacceptable risk to the patient. There should be no exclusion based on tumor size, multifocality or leptomeningeal or systemic metastases.
• Any patients who have not been seen by radiation therapist, or by a neurosurgeon should obtain these consultations, to verify whether there are existing therapies of known benefit that should be persued before (or instead of) antineoplastons.
• Patients must have evidence of brain tumor by gadolinium- enhanced MRI, or if MRI is contraindicated, contrast-enhanced CT scan performed within two weeks prior to entry. The minimum size of the tumor must be not smaller than 5 mm.
• 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 or renal insufficiency ,and a total serum bilirubin and creatinine level not higher than 2.5 mg/ml; and SGOT and SGPT not higher than five times the upper limit of normal.
• Patients may be male or female. If female, the patient must not be pregnant or breast-feeding an infant, and either incapable of becoming pregnant or currently using contraceptive methods. Acceptable methods include the birth control pill, use of a diaphragm, intrauterine device, or condom by the patient's sexual partner. If male, the patient should use appropriate contraception, such as condoms, during the study and at least 4 weeks following completion of the study.
• The patient must be over 1 year of age.
• Patient must sign the Informed Consent Form indicating an awareness of the experimental nature of this study. In the event that the patient has impairment of higher intellectual function, example aphasia, then the patient's legal next of kin or legal guardian must sign the Informed Consent Form indicating an awareness of the experimental nature of the study (Appendix B).
• Patient must fully recover from the operative procedure and have life expectancy of two months or more. The patient's Performance Status should be consistent with Outpatient therapy, i.e. 60% to 100% Karnofsky. The use of corticosteroids is permitted to reduce symptoms and signs attributed to cerebral edema. It is recommended that the smallest dose be used compatible with the preservation of optimal neurologic function.
• Patients must have a relatively normal hematopoietic function, WBC > 2000/mm3, and platelets > 50,000/mm3
• Patients may be male or female. If female, the patient must not be pregnant or breast-feeding an infant, and either incapable of becoming pregnant or currently using contraceptive methods. Acceptable methods include the birth control pill, use of a diaphragm, intrauterine device, or condom by the patient's sexual partner. If male, the patient should use appropriate contraception, such as condoms, during the study and at least 4 weeks following completion of the study.<5.0mg/dL, and SGOT and SGPT not higher than 5 times the upper limit.
• 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 neurologic function. Corticosteroids should be carefully monitored and recorded. Patients who are receiving corticosteroids must be on a fixed dose of corticosteroids for at least one week prior to baseline scan.
• Patients must recover from the adverse effects of previous therapy. At least eight weeks must have elapsed since the last dose of radiation therapy and at least four weeks must have elapsed since the last dose of chemotherapy (six weeks for nitrosoureas) or immunotherapy.

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.
• Patients with brain stem location of the tumor are excluded.

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