Antineoplaston Therapy in Treating Patients With Ependymoma
Condition: Ependymoma
MeSH terms: Ependymoma
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Patients with an ependymoma 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: 9.0
Sex: All
Minimum age: 6 Months
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Ependymoma; Anaplastic Ependymoma

Summary:

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

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed ependymoma that is unlikely to respond to existing therapy
             and for which no curative therapy exists

          -  Evidence of residual tumor (>= 5mm) by MRI scan performed within two weeks prior to
             study entry

          -  No brain stem tumors

        PATIENT CHARACTERISTICS:

        Age:

          -  6 months and over

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  At least 2 months

        Hematopoietic:

          -  WBC at least 2,000/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 failure

          -  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

          -  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