Antineoplaston Therapy in Treating Patients With 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