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 cancer of the esophagus.
- Provide antineoplastons A10 and AS2-1 as treatment for patients with incurable
adenocarcinoma of the esophagus.
- Describe the response to, tolerance to, and side effects of this regimen in these
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 2 months in the absence of disease progression or
unacceptable toxicity. Patients achieving a complete response (CR) continue treatment for at
least 8 months beyond CR. Patients achieving a partial response or stable disease continue
treatment until disease progression.
Tumors are measured 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 adenocarcinoma of the esophagus that is unlikely to respond
to existing therapy and for which no curative therapy exists
- Meets 1 of the following criteria:
- Metastatic disease
- Not curable with surgery or radiotherapy
- Measurable disease by MRI or CT scan
- 18 and over
- Karnofsky 60-100%
- At least 2 months
- WBC at least 2000/mm3
- Platelet count at least 50,000/mm3
- 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/ml
- No history of renal conditions that contraindicate high dosages of sodium
- No chronic or congestive heart failure
- No uncontrolled hypertension
- No other cardiovascular conditions that contraindicate high dosages of sodium
- 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 medical illness, psychiatric illness, or non-malignant systemic disease that would
preclude study treatment
- No active infection
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior immunotherapy and recovered
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- Concurrent steroids allowed
- At least 8 weeks since prior radiotherapy (except in patients with multiple tumors
who have received radiotherapy to some of their tumors) and recovered
- Recovered from prior surgery
- No prior antineoplaston therapy
- Prior cytodifferentiating agents allowed