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

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