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

Date de début de l'étude : 1 mars 1996

DISEASE CHARACTERISTICS: Histologically confirmed incurable primary malignant brain tumor that has progressed, recurred, or persisted after initial therapy (must have failed standard therapy). Evidence of residual tumor by MRI performed within two weeks prior to study entry PATIENT CHARACTERISTICS: Age: 6 months to 17 years Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 1,500/mm^3 Platelet count greater than 50,000/mm^3 Hepatic: No hepatic failure Bilirubin no greater than 2.5 mg/dL SGOT/SGPT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No severe heart disease No uncontrolled hypertension Pulmonary: No severe lung disease Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study participation No serious active infections or fever No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent immunomodulating agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No concurrent antineoplastic agents Endocrine therapy: Recovered from prior endocrine therapy Concurrent corticosteroids for cerebral edema allowed Radiotherapy: At least 8 weeks since prior radiotherapy (unless clear radiological evidence of progression) and recovered Surgery: At least 4 weeks since prior surgery (unless clear radiological evidence of progression) and recovered Other: No prior antineoplaston therapy