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 anaplastic astrocytoma that has not responded to previous treatment.
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with incurable anaplastic astrocytoma who experienced disease progression or
recurrence or have residual disease after standard therapy.
- Describe response, tolerance to, and side effects of this regimen in these patients.
OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and
antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose
Treatment continues for at least 3 months in the absence of toxicity and disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR.
Tumors are measured every 2 months during the first year, every 3 months for the second
year, every 3-4 months during the third and fourth years, every 4-6 months during the fifth
year, and yearly thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
- Histologically confirmed incurable anaplastic astrocytoma that has progressed,
recurred, or persisted after completion of standard therapy (including radiation
- Measurable disease by MRI or CT scan
- Tumor must be at least 5 mm
- Must have received prior standard therapy (i.e., radiation therapy, chemotherapy,
immunotherapy, or cytodifferentiating agent)
- 18 and over
- Karnofsky 60-100%
- At least 2 months
- WBC at least 2000/mm^3
- Platelet count at least 50,000/mm^3
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 5 times upper limit of normal
- No hepatic failure
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of
- No serious lung disease such as severe chronic obstructive pulmonary disease
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
- No active infection
- 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 agents
- Concurrent corticosteroids allowed
- At least 8 weeks since prior radiotherapy and recovered
- Fully recovered from any prior surgery
- Prior cytodifferentiating agent allowed
- No prior antineoplaston therapy