Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors

Inclusion 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