RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the
laboratory. Antineoplastons may inhibit the growth of cancer cells.
PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating
patients with recurrent or refractory mixed gliomas.
- Determine the safety and effectiveness of antineoplastons A10 and AS2-1 in patients
with incurable progressive, recurrent, or persistent mixed gliomas following standard
- Assess the response, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open label study.
Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1
by intravenous injection 6 times daily until the maximum tolerated dose is reached.
Treatment continues in the absence of toxicity and disease progression.
Tumors are measured every 2 months for 1 year, every 3 months for the second year, every 3-4
months for the third and fourth years, every 4-6 months for the fifth year, then annually
PROJECTED ACCRUAL: This study will accrue 20-40 patients.
- Histologically confirmed incurable primary mixed glioma that is progressive,
persistent, or recurrent following initial standard therapy, including radiation
- Measurable disease by CT scan or MRI
- Tumor must be at least 5 mm
- 18 and over
- Karnofsky 60-100%
- At least 2 months
- WBC at least 2000/mm3
- Platelet count at least 50,000/mm3
- No hepatic insufficiency
- Bilirubin no greater than 2.5 mg/mL
- SGOT and SGPT no greater than 5 times upper limit of normal
- No renal insufficiency
- Creatinine no greater than 2.5 mg/mL
- No history of renal conditions that contraindicate high dosages of sodium
- No known chronic heart failure
- No uncontrolled hypertension
- No history of congestive heart failure
- No other cardiovascular conditions that contraindicate high dosages of sodium
- No severe lung disease
- No severe chronic obstructive pulmonary disease
- 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:
- At least 4 weeks since immunotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- Concurrent corticosteroids allowed
- At least 8 weeks since prior radiotherapy (unless there is evidence of disease
- Fully recovered from prior surgery
- Prior cytodifferentiating agent allowed
- No prior antineoplaston therapy