Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Glioblastoma Multiforme

Fecha de inicio: 14 de marzo de 1996

DISEASE CHARACTERISTICS: Histologically confirmed incurable glioblastoma multiforme that has progressed, recurred, or persisted following completion of initial standard therapy (including radiotherapy and/or chemotherapy) Measurable disease by MRI or CT scan Brain stem tumor is excluded 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 2,000/mm3 Platelet count at least 50,000/mm3 Hepatic: No liver failure Bilirubin no greater than 2.5 mg/dL SGOT/SGPT no greater than 5 times upper limit Renal: No history of renal conditions that contraindicate high dosages of sodium Creatinine no greater than 2.5 mg/dL Cardiovascular: No uncontrolled hypertension No history of congestive heart failure No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No serious lung disease (e.g., severe COPD) Other: Not pregnant or nursing Fertile patients must use adequate contraception during and for 4 weeks after study No active infection No other serious medical or psychiatric conditions PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since immunotherapy No concurrent immunomodulating agents Chemotherapy: See Disease Characteristics At least 4 weeks since chemotherapy (unless radiologically proven progression) At least 6 weeks since nitrosoureas Endocrine therapy: Corticosteroids allowed Radiotherapy: See Disease Characteristics At least 8 weeks since radiotherapy (unless radiologically proven progression) Surgery: Recovered from prior surgery Other: No prior antineoplaston therapy Prior cytodifferentiating agent allowed