Trial Information

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

To study the safety and possible effectiveness of antineoplastons in patients with meningioma. To describe the patients response, tolerance to and the side effects of this regimen.

Inclusion Criteria

• Patient must have histologically confirmed incurable meningioma that has progressed , or recurred following surgical resection and radiotherapy. Patients who have not had surgery or radiotherapy are not eligible unless they have disease that is incurable by those treatment modalities.
• TThere will be no exclusion based on tumor size, multifocality, or leptomeningeal or systemic metastases.
• Radiologic evidence of residual or recurrent tumor by gadolinium-enhanced MRI or, if MRI is contraindicated, contrast -enhanced CT scan, performed within 14 days before initiating the treatment.
• Patients who have previously received standard therapy, such as 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 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, if necessary. It is recommended that the smallest dose be used and recorded.
• Minimal hematological parameters include hemoglobin of at least 9g/dl, a white blood count of at least 2000/ mm3 and a platelet count of at least 50,000/ mm3.
• Patients must have no evidence of hepatic insufficiency or renal insufficiency, and a total bilirubin and creatinine concentration in serum not higher than 2.5 mg/ml; and SGOT and SGPT not higher than five times the upper limit.
• 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), mifepristone or immunotherapy.

EXCLUSION CRITERIA

• Failure to meet all inclusion criteria.
• Patient either pregnant or breast-feeding an infant.
• Patient is a high medical or psychiatric risk, having non-malignant systemic disease which would, in the opinion of the investigator, make therapy with an investigational drug unwise.
• Patient is incompetent to give his informed consent to treatment. However, the patient may be admitted if a legally appointed guardian gives consent.
• Presence of active infection.
• Patients with known chronic heart failure and serious lung disease, such as severe COPD.
• Patients with hypertension history of congenital heart failure, or history of cardiovascular or renal conditions that medically contraindicate administration of high dosages of sodium are not to be enrolled on the treatment.
• Patients who have had prior Antineoplaston treatment should be excluded from this protocol.
• Patients who do not have adequate hepatic function.

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