Antineoplaston Therapy in Treating Children With Visual Pathway Glioma
Condition: Visual Pathway Glioma
MeSH terms: Glioma; Optic Nerve Glioma
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Children with a visual pathway glioma, which is not amenable to standard therapy or 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: 12.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: visual pathway glioma not amenable to standard therapy; visual pathway glioma not responding to standard therapy

Summary:

      RATIONALE: Current therapies for children with visual pathway gliomas, which are not amenable
      to or have not responded to standard therapy, 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 visual pathway gliomas, which are not amenable to or 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 with visual pathway gliomas, which are not amenable to
      or have not responded to standard therapy.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed (unless medically contraindicated) visual pathway glioma,
             which is not amenable to standard therapy or did not respond to standard therapy.

          -  Evidence of tumor by MRI scan performed within 2 weeks prior to the study entry

          -  Tumor must be at least 5 mm

          -  No brain stem tumors

        PATIENT CHARACTERISTICS:

        Age:

          -  6 months to 17 years

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  At least 2 months

        Hematopoietic:

          -  WBC at least 2000/mm3

          -  Platelet count greater than 50,000/mm3

        Hepatic:

          -  Bilirubin no greater than 2.5 mg/dL

          -  SGOT/SGPT no greater than 5 times upper limit of normal

          -  No hepatic failure

        Renal:

          -  Creatinine no greater than 2.5 mg/dL

          -  No renal insufficiency

          -  No history of renal conditions that contraindicate high dosages of sodium

        Cardiovascular:

          -  No severe heart disease

          -  No uncontrolled hypertension

          -  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

          -  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 and recovered (6 weeks for nitrosoureas)

          -  No concurrent antineoplastic agents

        Endocrine therapy:

          -  Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at
             least 1 week prior to study)

        Radiotherapy:

          -  At least 8 weeks since prior radiotherapy and recovered

        Surgery:

          -  Not specified

        Other:

          -  No prior antineoplaston therapy