Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Primary Malignant Brain Tumors

Fecha de inicio: 1 de febrero de 1996

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed incurable adult primary malignant brain tumor Evidence of progressive or recurrent tumor by MRI scan performed within 2 weeks prior to study entry Must have received and failed standard therapy Tumor must be at least 5 mm No brain stem tumors PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: Hematological function normal WBC at least 2000/mm^3 Platelet count at least 50,000/mm^3 Hepatic: No liver failure No evidence of hepatic insufficiency Bilirubin no greater than 2.5 mg/dL SGOT/SGPT no greater than 5 times upper limit of normal Renal: No evidence of renal insufficiency Creatinine no greater than 2.5 mg/dL No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: No uncontrolled hypertension No history of congestive heart failure No chronic heart failure No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No serious lung disease, such as severe chronic obstructive pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study participation No medical or psychiatric illness that would preclude study treatment No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No concurrent immunomodulating agents Chemotherapy: At least 4 weeks since prior chemotherapy, except in patients with disease progression during initial therapy At least 6 weeks since prior nitrosoureas, except in patients with disease progression during initial therapy No concurrent antineoplastic agents Endocrine therapy: Corticosteroids allowed Radiotherapy: See Disease Characteristics At least 8 weeks since prior radiotherapy, except in patients with disease progression during initial therapy Surgery: At least 4 weeks since prior surgery, except in patients with disease progression during initial therapy Other: Recovered from prior therapy Cytodifferentiating agents allowed