Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Mixed Glioma

Fecha de inicio: 1 de marzo de 1996

DISEASE CHARACTERISTICS: Histologically confirmed incurable primary mixed glioma that is recurrent or refractory following standard therapy, including radiation therapy Evidence of recurrent or refractory tumor by MRI scan performed within two weeks prior to study entry Must have received and failed standard therapy Tumor must be at least 5 mm PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 2000/mm3 Platelet count at least 50,000/mm3 Hepatic: No hepatic insufficiency Bilirubin no greater than 2.5 mg/mL SGOT and SGPT no greater than 5 times upper limit of normal Renal: No renal insufficiency Creatinine no greater than 2.5 mg/mL No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: No known chronic heart failure No uncontrolled hypertension No history of congestive heart failure No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No severe lung disease No severe chronic obstructive pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study No other severe medical illness No nonmalignant systemic disease No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: At least 8 weeks since prior radiotherapy (unless there is evidence of disease progression) Surgery: Fully recovered from prior surgery Other: Prior cytodifferentiating agent allowed No prior antineoplaston therapy