Antineoplaston Therapy in Treating Patients With Meningioma
Condition: Meningioma
MeSH terms: Meningioma
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Adults with a meningioma 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: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: adult meningioma; recurrent adult meningioma

Summary:

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

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed meningioma that has progressed or recurred following surgical
             resection and radiotherapy

          -  Evidence of residual tumor by MRI scan performed within two weeks prior to study entry

        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 2000/mm3

          -  Platelet count at least 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 history of renal conditions that contraindicate high dosages of sodium

        Cardiovascular:

          -  No chronic heart failure

          -  No uncontrolled hypertension

          -  No history of congestive heart failure

          -  No history of other cardiovascular conditions that contraindicate high dosages of
             sodium

        Pulmonary:

          -  No serious lung disease, such as chronic obstructive pulmonary disease

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 4 weeks after study

          -  No active infection

          -  No other serious concurrent disease

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  At least 4 weeks since prior immunotherapy and recovered

          -  No concurrent immunomodulatory agents

        Chemotherapy:

          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

          -  No concurrent antineoplastic agents

        Endocrine therapy:

          -  Concurrent corticosteroids allowed

          -  At least 4 weeks since prior therapy with mifepristone and recovered

        Radiotherapy:

          -  At least 8 weeks since prior radiotherapy and recovered

        Surgery:

          -  Recovered from prior surgery

        Other:

          -  Prior cytodifferentiating agent allowed

          -  No prior antineoplaston therapy