Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
Mixed Gliomas
About this trial
This is an interventional treatment trial for Mixed Gliomas focused on measuring recurrent adult mixed glioma, refractoy adult mixed glioma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed incurable primary mixed glioma that is recurrent or refractory following standard therapy, including radiation therapy Evidence of recurrent or refractory tumor by MRI scan performed within two 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/mm3 Platelet count at least 50,000/mm3 Hepatic: No hepatic insufficiency Bilirubin no greater than 2.5 mg/mL SGOT and SGPT no greater than 5 times upper limit of normal Renal: No renal insufficiency Creatinine no greater than 2.5 mg/mL No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: No known chronic heart failure No uncontrolled hypertension No history of congestive heart failure No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No severe lung disease No severe chronic obstructive pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study No other severe medical illness No nonmalignant systemic disease No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: At least 8 weeks since prior radiotherapy (unless there is evidence of disease progression) Surgery: Fully recovered from prior surgery Other: Prior cytodifferentiating agent allowed 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.