Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma
Condition: Adult Brain Tumor
MeSH terms: Astrocytoma
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Adults with an anaplastic astrocytoma 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: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: adult anaplastic astrocytoma

Summary:

      RATIONALE: Current therapies for adults with anaplastic astrocytoma 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 anaplastic astrocytoma.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on adults with anaplastic astrocytoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed diagnosis of anaplastic astrocytoma

          -  Tumor subtotally resected or biopsied prior to therapy

          -  Evidence of residual tumor by MRI scan performed within two weeks prior to study entry

          -  No brain stem tumors

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  More than 2 months

        Hematopoietic:

          -  WBC at least 1,500/mm^3

          -  Platelet count at least 50,000/mm^3

          -  Hemoglobin at least 10 g/dL

        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 renal failure

        Cardiovascular:

          -  No prior congestive heart failure

          -  No coronary artery disease

          -  No myocardial infarction within the past year

          -  No angina requiring medication

          -  No uncontrolled hypertension

        Pulmonary:

          -  No moderate to 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 active infection

          -  No other concurrent serious disease

          -  No other prior malignancy except carcinoma in situ of the cervix or superficial
             nonmelanoma skin cancer

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior immunotherapy

          -  No concurrent immunomodulating agents

        Chemotherapy:

          -  No prior myelosuppressive chemotherapy

        Endocrine therapy:

          -  Concurrent corticosteroids for cerebral edema allowed

        Radiotherapy:

          -  No prior myelosuppressive radiotherapy

          -  No concurrent radiotherapy

        Surgery:

          -  See Disease Characteristics

          -  Recovered from any prior surgery

        Other:

          -  No prior cytodifferentiating agents

          -  No prior antineoplaston therapy

          -  No other concurrent antineoplastic agents