Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors
Primitive Neuroectodermal Tumor
About this trial
This is an interventional treatment trial for Primitive Neuroectodermal Tumor focused on measuring Metastatic Primitive Neuroectodermal Tumor, Recurrent Primitive Neuroectodermal Tumor, Refractory Primitive Neuroectodermal Tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed incurable primitive neuroectodermal tumors outside the central nervous system that are unlikely to respond to existing therapy, meeting 1 of the following criteria: Metastatic disease Progressive, recurrent, or refractory disease after initial therapy, including surgery, chemotherapy, and/or radiotherapy Measurable disease by MRI or CT scan Tumor must be at least 2 cm PATIENT CHARACTERISTICS: Age: 6 months and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 2,000/mm^3 Platelet count at least 50,000/mm^3 Hepatic: No hepatic insufficiency Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal Renal: No 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 history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No serious lung disease, such as 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 nonmalignant systemic disease Not a high medical or psychiatric risk PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No concurrent immunomodulating agents Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: See Disease Characteristics At least 8 weeks since prior radiotherapy Surgery: See Disease Characteristics Recovered from prior surgery Other: Prior cytodifferentiating agents allowed No prior antineoplastons No other concurrent antineoplastic agents
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.