Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors
Childhood Brain Tumor
About this trial
This is an interventional treatment trial for Childhood Brain Tumor focused on measuring childhood anaplastic astrocytoma, recurrent childhood anaplastic astrocytoma, childhood glioblastoma multiforme, recurrent childhood glioblastoma multiforme, childhood brainstem glioma, recurrent childhood brainstem glioma, childhood primitive neuroectodermal tumor, recurrent childhood primitive neuroectodermal tumor
Eligibility Criteria
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
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.