Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
Condition: Anaplastic Astrocytoma
MeSH terms: Astrocytoma
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: persistent anaplastic astrocytoma; recurrent anaplastic astrocytoma; adult anaplastic astrocytoma

Summary:

      RATIONALE: Current therapies for adults with anaplastic astrocytomas that have not responded
      to standard therapy 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 anaplastic astrocytomas that have not responded to standard therapy.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on adults with anaplastic astrocytomas that have not responded to
      standard therapy.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed incurable adult anaplastic astrocytoma

          -  Evidence of progressive or recurrent tumor by MRI scan performed within 2 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/mm^3

          -  Platelet count at least 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 history of congestive heart failure

          -  No history of other cardiovascular conditions that contraindicate high dosages of
             sodium

        Pulmonary:

          -  No serious lung disease such as severe 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 immunomodulating agents

        Chemotherapy:

          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

          -  No concurrent antineoplastic agents

        Endocrine therapy:

          -  Concurrent corticosteroids allowed

        Radiotherapy:

          -  At least 8 weeks since prior radiotherapy and recovered

        Surgery:

          -  Fully recovered from any prior surgery

        Other:

          -  Prior cytodifferentiating agent allowed

          -  No prior antineoplaston therapy