Antineoplaston Therapy in Treating Patients With Brain Tumors
Condition: Refractory Brain Tumors
MeSH terms: Brain Neoplasms
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Adults with a persistent or recurrent 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: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Anaplastic astrocytoma; Anaplastic astrocytoma/Mixed; Astrocytoma; Astrocytoma/Pilocytic; Brainstem glioma; Glioblastoma multiforme; Glioma; Neurocytoma; Primitive neuroectodermal tumor; Tectal glioma

Summary:

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

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed brain tumor (except brain stem locations) that is unlikely to
             respond to existing therapy and for which no curative therapy exists

          -  Evidence of persistent or recurrent brain tumor by MRI scan performed within two weeks
             prior to study entry

          -  Tumor must be at least 5 mm

          -  Ineligible for other Burzynski Research Institute, Inc. brain tumor protocols

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  At least 2 months

        Hematopoietic:

          -  Hemoglobin at least 9 g/dL

          -  WBC at least 2,000/mm^3

          -  Platelet count at least 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 history of 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 concurrent 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 a stable dose for at
             least 1 week prior to study entry)

        Radiotherapy:

          -  At least 8 weeks since prior radiotherapy

        Surgery:

          -  Must recover from prior surgery

        Other:

          -  Prior cytodifferentiating agent allowed

          -  No prior antineoplaston therapy