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
children with recurrent or refractory high grade glioma.
- Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with
high-grade glioma by determining the proportion of patients who experience an objective
- Evaluate the adverse effects of and tolerance to this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of intravenous antineoplaston A10 and
antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment
continues for at least 12 months in the absence of unacceptable toxicity or disease
progression. After 12 months, patients with responding or stable disease may continue
Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth
years, every 6 months for the fifth and sixth years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
- Histologically confirmed incurable high-grade glioma, glioblastoma multiforme, or
anaplastic astrocytoma that is refractory or recurrent, or with residual tumor after
standard therapy, including radiotherapy
- Evidence of tumor by gadolinium-enhanced MRI or contrast-enhanced CT scan
- No brain stem tumor
- 6 months to 17 years
- Karnofsky 60-100%
- At least 2 months
- WBC greater than 1,500/mm^3
- Platelet count greater than 50,000/mm^3
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of normal
- No hepatic failure
- Creatinine no greater than 2.5 mg/dL
- No renal insufficiency
- No severe heart disease
- No uncontrolled hypertension
- No history of congestive heart failure
- No severe lung disease
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
- No serious active infections or fever
- No other serious concurrent disease
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulating agents
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent antineoplastic therapy
- Concurrent corticosteroids allowed
- See Disease Characteristics
- At least 8 weeks since prior radiotherapy and recovered
- Not specified
- No prior antineoplaston therapy