Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors
Condition: Malignant Brain Tumors
MeSH terms: Brain Neoplasms
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Adults with a primary malignant brain tumor 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: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: adult glioblastoma multiforme; adult anaplastic astrocytoma; adult anaplastic astrocytoma/Mixed

Summary:

      RATIONALE: Current therapies for adults with primary malignant brain tumors 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 primary malignant brain tumors 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 primary malignant brain tumors that have not
      responded to standard therapy.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed incurable adult primary malignant brain
             tumor

          -  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

          -  No brain stem tumors

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  At least 2 months

        Hematopoietic:

          -  Hematological function normal

          -  WBC at least 2000/mm^3

          -  Platelet count at least 50,000/mm^3

        Hepatic:

          -  No liver failure

          -  No evidence of hepatic insufficiency

          -  Bilirubin no greater than 2.5 mg/dL

          -  SGOT/SGPT no greater than 5 times upper limit of normal

        Renal:

          -  No evidence of renal insufficiency

          -  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 chronic heart failure

          -  No 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
             participation

          -  No medical or psychiatric illness that would preclude study treatment

          -  No active infection

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  At least 4 weeks since prior immunotherapy

          -  No concurrent immunomodulating agents

        Chemotherapy:

          -  At least 4 weeks since prior chemotherapy, except in patients with disease progression
             during initial therapy

          -  At least 6 weeks since prior nitrosoureas, except in patients with disease progression
             during initial therapy

          -  No concurrent antineoplastic agents

        Endocrine therapy:

          -  Corticosteroids allowed

        Radiotherapy:

          -  See Disease Characteristics

          -  At least 8 weeks since prior radiotherapy, except in patients with disease progression
             during initial therapy

        Surgery:

          -  At least 4 weeks since prior surgery, except in patients with disease progression
             during initial therapy

        Other:

          -  Recovered from prior therapy

          -  Cytodifferentiating agents allowed