AAPhase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Anaplastic Astrocytoma

Date de début de l'étude : 1 mars 1996

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed incurable adult anaplastic astrocytoma 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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 2000/mm^3 Platelet count at least 50,000/mm^3 Hepatic: Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal No hepatic failure Renal: 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 history of 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 No active infection 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: Concurrent corticosteroids allowed Radiotherapy: At least 8 weeks since prior radiotherapy and recovered Surgery: Fully recovered from any prior surgery Other: Prior cytodifferentiating agent allowed No prior antineoplaston therapy