Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Mixed Glioma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed incurable primary mixed glioma that is progressive,
persistent, or recurrent following initial standard therapy, including radiation
therapy

- Measurable disease by CT scan or MRI

- 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/mm3

- Platelet count at least 50,000/mm3

Hepatic:

- No hepatic insufficiency

- Bilirubin no greater than 2.5 mg/mL

- SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

- No renal insufficiency

- Creatinine no greater than 2.5 mg/mL

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

Cardiovascular:

- No known chronic heart failure

- No uncontrolled hypertension

- No history of congestive heart failure

- No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

- No severe lung disease

- No severe chronic obstructive pulmonary disease

Other:

- Not pregnant or nursing

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

- No other severe medical illness

- No nonmalignant systemic disease

- No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since immunotherapy

Chemotherapy:

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

Endocrine therapy:

- Concurrent corticosteroids allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy (unless there is evidence of disease
progression)

Surgery:

- Fully recovered from prior surgery

Other:

- Prior cytodifferentiating agent allowed

- No prior antineoplaston therapy