Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors
Malignant Brain Tumors
About this trial
This is an interventional treatment trial for Malignant Brain Tumors focused on measuring adult glioblastoma multiforme, adult anaplastic astrocytoma, adult anaplastic astrocytoma/Mixed
Eligibility Criteria
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
Sites / Locations
- Burzynski Clinic
Arms of the Study
Arm 1
Experimental
Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.