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 studies the effectiveness of antineoplaston therapy in treating
patients who have glioblastoma multiforme.
- Determine the objective response rate to escalating doses of antineoplastons A10 and
AS2-1 in patients with glioblastoma multiforme.
- Assess tolerance to and side effects of this regimen in these patients.
OUTLINE: Patients receive gradually escalating doses of intravenous antineoplaston A10 and
antineoplaston AS2-1 6 times daily until the maximum tolerated dose is reached. Treatment
continues for at least 2 months in the absence of unacceptable toxicity or disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after CR.
Tumors are measured after 1 month, every 1-2 months for 2 years, every 3 months for 1 year,
every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: Not specified
- Histologically or cytologically confirmed glioblastoma multiforme
- Tumor subtotally resected or biopsied
- Radiologic evidence of residual or recurrent tumor by gadolinium-enhanced MRI,
CT scan, or positron-emission tomography
- No brain stem tumor
- 18 and over
- Karnofsky 60-100%
- More than 4 months
- WBC at least 1,500/mm^3
- Platelet count at least 50,000/mm^3
- Hemoglobin at least 10 g/dL
- No hepatic failure
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 5 times upper limit of normal
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that would contraindicate high dosages of sodium
- No uncontrolled hypertension
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- No prior immunotherapy
- No concurrent immunomodulatory agents
- No prior chemotherapy
- No concurrent antineoplastic agents
- Concurrent corticosteroids for cerebral edema allowed
- No prior radiotherapy
- See Disease Characteristics
- Recovered from any prior surgery