Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
Condition: Mixed Gliomas
MeSH terms: Glioma
Intervention: Atengenal; Astugenal
Intervention description: Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).; Adults with a recurrent or refractory mixed 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: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: recurrent adult mixed glioma; refractoy adult mixed glioma

Summary:

      RATIONALE: Current therapies for adults with recurrent or refractory mixed 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 adults with recurrent or refractory
      mixed gliomas.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on adults with recurrent or refractory mixed gliomas.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed incurable primary mixed glioma that is recurrent or
             refractory following standard therapy, including radiation therapy

          -  Evidence of recurrent or refractory tumor by MRI scan performed within two weeks prior
             to study entry

          -  Must have received and failed standard therapy

          -  Tumor must be at least 5 mm

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  At least 2 months

        Hematopoietic:

          -  WBC at least 2000/mm3

          -  Platelet count at least 50,000/mm3

        Hepatic:

          -  No hepatic insufficiency

          -  Bilirubin no greater than 2.5 mg/mL

          -  SGOT and SGPT no greater than 5 times upper limit of normal

        Renal:

          -  No renal insufficiency

          -  Creatinine no greater than 2.5 mg/mL

          -  No history of renal conditions that contraindicate high dosages of sodium

        Cardiovascular:

          -  No known chronic heart failure

          -  No uncontrolled hypertension

          -  No history of congestive heart failure

          -  No other cardiovascular conditions that contraindicate high dosages of sodium

        Pulmonary:

          -  No severe lung disease

          -  No severe chronic obstructive pulmonary disease

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 4 weeks after study

          -  No other severe medical illness

          -  No nonmalignant systemic disease

          -  No active infection

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  At least 4 weeks since immunotherapy

        Chemotherapy:

          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

        Endocrine therapy:

          -  Concurrent corticosteroids allowed

        Radiotherapy:

          -  At least 8 weeks since prior radiotherapy (unless there is evidence of disease
             progression)

        Surgery:

          -  Fully recovered from prior surgery

        Other:

          -  Prior cytodifferentiating agent allowed

          -  No prior antineoplaston therapy