Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma
Condition: High Grade Glioma
MeSH terms: Glioma
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Children with a recurrent/progressive high grade glioma 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: 9.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Years
Healthy volunteers: No
Keywords: childhood anaplastic astrocytoma; childhood glioblastoma multiforme

Summary:

      RATIONALE: Current therapies for children with recurrent/progressive high grade gliomas
      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
      recurrent/progressive high grade gliomas.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on children (> 6 months of age) with recurrent/progressive high
      grade gliomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed high-grade glioma (glioblastoma multiforme or anaplastic
             astrocytoma) that is recurrent or progressive or with residual tumor after standard
             therapy, including radiotherapy

          -  Measurable tumor by MRI scan performed within two weeks prior to study entry

          -  Male or female patients

          -  Children 6 months to 17 years

          -  Performance status: Karnofsky 60-100%

          -  Life expectancy of at least 2 months

          -  WBC greater than 1,500/mm^3

          -  Platelet count greater than 50,000/mm^3

          -  No evidence of hepatic or renal insufficiency and a total bilirubin and serum
             creatinine no greater than 2.5 mg/dL and SGOT/SGPT no greater than 5 times upper limit
             of normal

          -  Must have recovered from adverse effect of previous therapy

          -  At least 8 weeks elapsed since last dose of radiation

          -  At least 4 weeks elapsed since last dose of chemotherapy (6 weeks for nitrosoureas)

          -  Corticosteroids permitted using the smallest dose that is compatible with preservation
             of optimal neurologic function

          -  Acceptable methods of birth control (in females of child-bearing potential or in
             sexually active males)during and up to four weeks following completion of study

        Exclusion Criteria:

          -  Prior A10 and AS2-1 treatment

          -  Severe heart disease

          -  Uncontrolled hypertension

          -  Lung disease

          -  Hepatic failure

          -  Serious active infections, fever or other serious concurrent disease that would
             interfere with the evaluation of the treatment drug.

          -  Pregnant or nursing

          -  Serious concurrent disease

          -  Concurrent antineoplastic or immunomodulatory agents