Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors
Condition: Childhood Brain Tumor
MeSH terms: Brain Neoplasms
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Children with a primary malignant brain tumor 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: 8.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Years
Healthy volunteers: No
Keywords: childhood anaplastic astrocytoma; recurrent childhood anaplastic astrocytoma; childhood glioblastoma multiforme; recurrent childhood glioblastoma multiforme; childhood brainstem glioma; recurrent childhood brainstem glioma; childhood primitive neuroectodermal tumor; recurrent childhood primitive neuroectodermal tumor

Summary:

      RATIONALE: Current therapies for children with primary malignant brain tumors provide limited
      benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it
      may prove beneficial in the treatment of children with primary malignant brain tumors.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on children with primary malignant brain tumors.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed incurable primary malignant brain tumor that has progressed,
             recurred, or persisted after initial therapy (must have failed standard therapy).

          -  Evidence of residual tumor by MRI performed within two weeks prior to study entry

        PATIENT CHARACTERISTICS:

        Age:

          -  6 months to 17 years

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  At least 2 months

        Hematopoietic:

          -  WBC at least 1,500/mm^3

          -  Platelet count greater than 50,000/mm^3

        Hepatic:

          -  No hepatic failure

          -  Bilirubin no greater than 2.5 mg/dL

          -  SGOT/SGPT no greater than 5 times upper limit of normal

        Renal:

          -  Creatinine no greater than 2.5 mg/dL

        Cardiovascular:

          -  No severe heart disease

          -  No uncontrolled hypertension

        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 concurrent 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:

          -  Recovered from prior endocrine therapy

          -  Concurrent corticosteroids for cerebral edema allowed

        Radiotherapy:

          -  At least 8 weeks since prior radiotherapy (unless clear radiological evidence of
             progression) and recovered

        Surgery:

          -  At least 4 weeks since prior surgery (unless clear radiological evidence of
             progression) and recovered

        Other:

          -  No prior antineoplaston therapy