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 advanced mesothelioma.
- Provide treatment with antineoplastons A10 and AS2-1 to patients with stage IV
- Describe the response to, tolerance to, and side effects of this regimen in these
OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and
antineoplaston AS2-1 IV six times per day until the maximum dose is reached.
Treatment continues for at least 3 months in the absence of disease progression or
unacceptable toxicity. After 3 months, patients with stable or responding disease may
continue treatment. Patients achieving complete response (CR) continue treatment for at
least 8 months beyond CR.
Patients are followed every 2 months for 1 year and then every 3 months for the second year.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
- Histologically confirmed stage IV mesothelioma that is unlikely to respond to
existing therapy and for which no curative therapy exists
- Evidence of disease by CT scan or MRI
- 1 and over
- Karnofsky 60-100%
- At least 2 months
- WBC at least 2,000/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
- Hepatic function adequate
- Creatinine no greater than 2.5 mg/dL
- No renal insufficiency
- No history of renal conditions that contraindicate high dosages of sodium
- No uncontrolled hypertension
- No history of congestive heart failure
- No cardiovascular conditions that contraindicate high dosages of sodium
- No serious lung disease (e.g., chronic obstructive pulmonary disease)
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
- Not at high medical or psychiatric risk
- No nonmalignant systemic disease
- No active infection
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulatory agents
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- Concurrent corticosteroids allowed
- At least 8 weeks since prior radiotherapy (or less if multiple tumors) and recovered
- Recovered from prior surgery
- Prior cytodifferentiating agents allowed
- No prior antineoplastons
- No other concurrent antineoplastic agents