Trial Information

Summary: A phase II study of Antineoplastons A10 And AS2-1 In Patients With Brain Tumors

Study the safety and possible effectiveness of Antineoplastons infusions in patients with serious or immediately life threatening brain tumors. To describe the patients' response, tolerance to and the side effects of this regimen.

Inclusion Criteria

• 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 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. The minimum size of the tumor must be not smaller than 5 mm. The patients admitted to the study under this protocol are those who cannot be admitted to the studies under the following study protocols: BT-6, BT-7, BT-8, BT-11, BT-12, BT-13, BT-14, BT-15, BT-16, BT-17, BT-18, BT-19, BT-20, BT-21, BT-22, BT-23, BT-24, BT-25, BT-26, BT-27, and BT-28.
• Patients who have previously received radiation therapy, chemotherapy, immunotherapy or cytodifferentiating agent are eligible.
• 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.
• Patient's age: 18 years old and over.
• 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 who are receiving corticosteroids must be on a fixed dose of corticosteroids for at least one week prior to baseline scan.
• Minimal hematological parameters include a hemoglobin of at least 9g/dL, a white blood count of at least 2000 and a platelet count of at least 50,000.
• Patient must have a normal total bilirubin level and SGOT and SGPT not higher than five times the upper limit of normal. Creatinine concentration in serum not higher than 2.5 mg/dL.

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 hypertension, history of congestive heart failure, or history of cardiovascular renal conditions that medically contraindicate administration of high dosages of sodium are not to be enrolled on treatment.

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