Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma
Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma
RATIONALE: Current therapies for adult recurrent/progressive low grade astrocytoma provide
 limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest
 that it may prove beneficial in the treatment of adult recurrent/progressive low grade
 astrocytoma.

 PURPOSE: This study is being performed to determine the effects (good and bad) that
 Antineoplaston therapy has on adults with a recurrent/progressive low grade astrocytoma.
OVERVIEW: This is a single arm, open-label study in which adults with a recurrent/progressive
 low grade astrocytoma receive gradually escalating doses of intravenous Antineoplaston
 therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment
 continues for at least 12 months in the absence of disease progression or unacceptable
 toxicity.

 OBJECTIVES:

 -  To determine the efficacy of Antineoplaston therapy in adults with a
 recurrent/progressive low grade astrocytoma, as measured by an objective response to
 therapy (complete response, partial response or stable disease).

 -  To determine the safety and tolerance of Antineoplaston therapy in adults with a
 recurrent/progressive low grade astrocytoma.

 -  To determine objective response, tumor size is measured utilizing MRI scans, which are
 performed every 8 weeks for the first two years, every 3 months for the third and fourth
 years, every 6 months for the 5th and sixth years, and annually thereafter.

 PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.
DISEASE CHARACTERISTICS:

 -  Histologically or cytologically confirmed low-grade astrocytoma that has progressed,
 recurred, or persisted after initial therapy, including radiotherapy

 -  Previously treated with at least 1 prior standard therapy (e.g., radiotherapy,
 chemotherapy, immunotherapy, or cytodifferentiating agent)

 -  Measurable tumor by MRI scan performed within two weeks prior to study entry

 -  Tumor must be at least 5 mm

 -  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 2,000/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 renal insufficiency

 -  No history of renal conditions that contraindicate high dosages of sodium

 Cardiovascular:

 -  No uncontrolled hypertension

 -  No chronic heart failure

 -  No history of congestive heart failure

 -  No history of other cardiovascular conditions that contraindicate high dosages of
 sodium

 Pulmonary:

 -  No severe lung disease (e.g., chronic obstructive pulmonary disease)

 Other:

 -  Not pregnant or nursing

 -  Fertile patients must use effective contraception during and for 4 weeks after study
 participation

 -  No other concurrent serious disease

 -  No active infection

 PRIOR CONCURRENT THERAPY:

 Biologic therapy:

 -  See Disease Characteristics

 -  At least 4 weeks since prior immunotherapy and recovered

 -  No concurrent immunomodulating agents

 Chemotherapy:

 -  See Disease Characteristics

 -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

 -  No concurrent antineoplastic agents

 Endocrine therapy:

 -  Concurrent corticosteroids allowed

 Radiotherapy:

 -  See Disease Characteristics

 -  At least 8 weeks since prior radiotherapy and recovered

 Surgery:

 -  Must recover from prior surgery

 Other:

 -  No prior antineoplastons