Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
Condition: Childhood CNS Primitive Neuroectodermal Tumor
MeSH terms: Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Recurrent primitive neuroectodermal tumor

Summary:

      RATIONALE: Current therapies for children with primitive neuroectodermal tumors that have not
      responded to standard therapy provide very limited benefit to the patient. The anti-cancer
      properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of
      children with primitive neuroectodermal tumors that have not responded to standard therapy.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on children (> 6 months of age) with primitive neuroectodermal
      tumors that has not responded to standard therapy.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed (except if medically contraindicated) incurable primitive
             neuroectodermal tumor

          -  Evidence of progressive or recurrent tumor by MRI scan performed within 2 weeks prior
             to study entry

          -  Must have received and failed prior standard therapy

          -  Tumor must be at least 5 mm

        PATIENT CHARACTERISTICS:

        Age:

          -  6 months to 17 years

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  At least 2 months

        Hematopoietic:

          -  WBC at least 2000/mm^3

          -  Platelet count greater than 50,000/mm^3

        Hepatic:

          -  Bilirubin no greater than 2.5 mg/dL

          -  SGOT and SGPT no greater than 5 times upper limit of normal

          -  No hepatic insufficiency

        Renal:

          -  Creatinine no greater than 2.5 mg/dL

          -  No history of renal conditions that contraindicate high dosages of sodium

        Cardiovascular:

          -  No uncontrolled hypertension

          -  No severe heart disease

          -  No history of congestive heart failure

          -  No other cardiovascular conditions that contraindicate high dosages of sodium

        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 concomitant 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:

          -  Concurrent corticosteroids for cerebral edema allowed (must be on a stable dose for at
             least 1 week prior to study entry)

        Radiotherapy:

          -  At least 8 weeks since prior radiotherapy and recovered

        Surgery:

          -  Not specified

        Other:

          -  No prior antineoplaston treatment