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

Date de début de l'étude : 1 avril 1995

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed diagnosis of anaplastic astrocytoma Tumor subtotally resected or biopsied prior to therapy Evidence of residual tumor by MRI scan performed within two weeks prior to study entry No brain stem tumors PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: More than 2 months Hematopoietic: WBC at least 1,500/mm^3 Platelet count at least 50,000/mm^3 Hemoglobin at least 10 g/dL 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 renal failure Cardiovascular: No prior congestive heart failure No coronary artery disease No myocardial infarction within the past year No angina requiring medication No uncontrolled hypertension Pulmonary: No moderate to 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 active infection No other concurrent serious disease No other prior malignancy except carcinoma in situ of the cervix or superficial nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy No concurrent immunomodulating agents Chemotherapy: No prior myelosuppressive chemotherapy Endocrine therapy: Concurrent corticosteroids for cerebral edema allowed Radiotherapy: No prior myelosuppressive radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Recovered from any prior surgery Other: No prior cytodifferentiating agents No prior antineoplaston therapy No other concurrent antineoplastic agents