Trial Information

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

To study the safety and possible effectiveness of antineoplastons in patients with incurable mixed glioma for patients who developed progression during standard therapy, including radiation therapy and/or chemotherapy, or developed recurrence, or have residual tumor following standard therapy.
To describe the patients' response, tolerance to and the side effects of this regimen.

Inclusion Criteria:
Patient must have histologically confirmed incurable primary malignant brain tumor that has progressed , recurred or persisted ( with radiologic findings that are highly suggestive for viable residual tumor, in the opinion of the consulting radiologist) following completion of initial standard therapy, including radiation therapy. An enhancing rim around the operative site on scan could be due to granulation tissue and would not generally qualify as sufficient evidence of residual tumor. At least eight (8) weeks must have elapsed since the last dose of radiation therapy and at least four (4) weeks must have elapsed since the last dose of chemotherapy ( six (6) weeks for nitrosoureas) or immunotherapy.
Since the full effectiveness of initial therapy ( including radiation therapy ) may not be seen until a few months after the initial therapy is completed , it is very difficult to analyze the effectiveness of initial therapy before the patient has completed treatment and follow-up. Because of this treatment decisions are usually not made on the base of radiological studies performed earlier than four (4) weeks following completion of radiation therapy. However, patients with clear evidence of disease progression during the initial therapy ( documented by the consulting radiologist’s written interpretation that radiologic studies show unequivocal evidence of failure of initial therapy with disease progression) may be enrolled less than eight weeks following the last dose of radiation therapy.
There will be no exclusion based on tumor size, multifocality, or leptomeningeal or systemic metastases.
Patients must have measurable disease by contrast enhanced CT scan or MRI performed within fourteen days of the beginning of treatment with the minimum size of the lesion to be considered malignant and measurable not less than 5 mm in largest diameter.
Patients who have previously received standard therapy, such as radiation therapy, chemotherapy, immunotherapy or cytodifferentiating agent are eligible and patients who did not have standard therapy are not eligible for this protocol.
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 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 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.
Patient must have a relatively normal hematological, hepatic and renal function, 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 who have not been seen by a radiation therapist and by a neurosurgeon should obtain these consultations , to verify whether there are existing therapies of known benefits that should be pursued before (or instead of ) antineoplastons.

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 are excluded unless the blood pressure is adequately controlled. Patients who have had prior Antineoplaston treatment should be excluded from this protocol.
• Patients who do not have adequate hepatic function.
• 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.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.