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 ependymoma.
- Determine the antitumor activity of antineoplastons A10 and AS2-1 in patients with
ependymoma by determining the proportion of patients who experience an objective tumor
- Evaluate the adverse side effects and tolerance to 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 for at least 12 months in the absence of disease progression and
unacceptable toxicity. After 12 months, patients with stable disease may continue treatment.
Tumors are measured at least every 8 weeks during the first 2 years, every 3 months during
the third and fourth years, every 6 months during the fifth and sixth years, and yearly
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
- Histologically confirmed ependymoma that is unlikely to respond to existing therapy
and for which no curative therapy exists
- Evidence of tumor by MRI or CT scan
- Tumor must be at least 5 mm
- No brain stem tumors
- 6 months and over
- Karnofsky 60-100%
- At least 2 months
- WBC at least 2,000/mm3
- Platelet count greater than 50,000/mm3
- 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 failure
- No history of renal conditions that contraindicate high dosages of sodium
- No severe heart disease
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of
- 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 and recovered (6 weeks for nitrosoureas)
- No concurrent antineoplastic agents
- Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at
least 1 week prior to study)
- At least 8 weeks since prior radiotherapy and recovered
- Not specified
- No prior antineoplaston therapy