Antineoplaston Therapy in Treating Children With Rhabdoid Tumor of the Central Nervous System
Condition: Rhabdoid Neoplasm of CNS
MeSH terms: Rhabdoid Tumor; Central Nervous System Neoplasms
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Children with a Rhabdoid 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: 4.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: childhood rhabdoid tumor

Summary:

      RATIONALE: Current therapies for childhood Rhabdoid tumors provide limited benefit to the
      patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
      beneficial in the treatment of childhood Rhabdoid tumors.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on children (> 6 months of age) with Rhabdoid tumors.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed Rhabdoid tumor of the central nervous system that is unlikely
             to respond to existing therapy and for which no curative therapy exists

          -  Measurable tumor by MRI scan performed within two weeks prior to study entry

          -  Tumor must be at least 5 mm

        PATIENT CHARACTERISTICS:

        Age:

          -  6 months to 17 years

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  At least 2 months

        Hematopoietic:

          -  WBC at least 2000/mm^3

          -  Platelet count greater than 50,000/mm^3

        Hepatic:

          -  Bilirubin no greater than 2.5 mg/dL

          -  SGOT and 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 uncontrolled hypertension

          -  No severe heart disease

          -  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 concomitant 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 (6 weeks for nitrosoureas) and recovered

          -  No concurrent antineoplastic agents

        Endocrine therapy:

          -  Concurrent corticosteroids for cerebral edema allowed (must be on a stable dose for at
             least 1 week before study entry)

        Radiotherapy:

          -  At least 8 weeks since prior radiotherapy and recovered

        Surgery:

          -  Not specified

        Other:

          -  No prior antineoplaston treatment