Trial Information

Summary: A phase II study of Antineoplastons A10 and AS2-1 in Patients with Anaplastic Astrocytoma

Determine the objective response rate in patients with anaplastic astrocytoma after subtotal resection to combined therapy with A10 at highest tolerated dose or effective dose, not exceeding 20.0 g/kg/day and AS2-1, 0.2 to 0.4g/kg/day administered by intermittent I.V. injections indefinitely until the development of progressive disease. Describe the patients' tolerance to and the side effects of this regimen.

Inclusion Criteria

• There 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 7 days before initiating the study and no earlier than 4 weeks following tumor resection or biopsy.
• Patients who have previously received radiation therapy, chemotherapy, immunotherapy or cytodifferentiating agents are not 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 be 18 years of age or older.
• 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 be geographically accessible for follow up.
• Patient must fully recover from the operative procedure and have life expectancy of four months or more. The patient's Performance Status should be consistent with Outpatient therapy v 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 necrologic function.
• Minimal hematological parameters include hemoglobin of at least 10g/dL, a white blood count of at least 1500 and a platelet count of at least 50,000.
• Evidence of adequate renal and hepatic insufficiency, total bilirubin <0.5 mg/dL, and SCOT and SGPT not higher than 5 times the upper limit.

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 nonmalignant 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.
• Myelosuppressive chemotherapy or myelosuppressive radiotherapy
• Concurrent chemotherapy or radiation therapy.
• Patients with a history of malignancy other than in situ carcinoma of the cervix, or superficial, non-melanoma skin cancer.
• Patients with known heart and lung disease, such a as any history of CHF, coronary artery disease ( as manifested by MI within the past year or angina requiring medication,) or moderate to severe COPD.
• Patients with hypertension are excluded unless the blood pressure is adequately controlled.
• Patients who do not have adequate renal and hepatic functions (6.l k).
• Brain stem location of the tumor is excluded.

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