Antineoplaston Therapy in Treating Patients With Brain Stem Glioma
Condition: Brain Stem Gliomas
MeSH terms: Glioma
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Patients with a brain stem 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: 40.0
Sex: All
Minimum age: 6 Months
Maximum age: 99 Years
Healthy volunteers: No
Keywords: recurrent adult brain stem glioma; untreated adult brain stem glioma; untreated childhood brain stem glioma; recurrent childhood brain stem glioma

Summary:

      RATIONALE: Current therapies for a brain stem glioma provide very limited benefit to the
      patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
      beneficial in the treatment of brain stem gliomas.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on children (> 6 months of age) and adults with newly-diagnosed or
      recurrent brain stem gliomas.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed (except if medically contraindicated) brain stem glioma that
             is unlikely to respond to existing therapy and for which no curative therapy exists.

          -  Tumor must be at least 5 mm in maximum diameter

        PATIENT CHARACTERISTICS:

        Age:

          -  6 months or greater

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  At least 2 months

        Hematopoietic:

          -  WBC at least 2,000/mm^3

          -  Platelet count greater than 50,000/mm^3

        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 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
             participation

          -  No serious active infections or fever

          -  No other serious concomitant disease

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  At least 4 weeks since prior immunotherapy

          -  No concurrent immunomodulating agents

        Chemotherapy:

          -  At least 4 weeks since prior chemotherapy (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 before study entry)

        Radiotherapy:

          -  At least 8 weeks since prior radiotherapy

        Surgery:

          -  Not specified

        Other:

          -  No prior Antineoplaston therapy