Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of the Esophagus

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 2000/mm3

- Platelet count at least 50,000/mm3

Hepatic:

- No hepatic failure

- Bilirubin no greater than 2.5 mg/dL

- SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

- Creatinine no greater than 2.5 mg/ml

- No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

- No chronic or congestive heart failure

- No uncontrolled hypertension

- No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

- No serious lung disease, such as severe chronic obstructive pulmonary disease

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 4 weeks after study
participation

- No medical illness, psychiatric illness, or non-malignant systemic disease that would
preclude study treatment

- No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

- Concurrent steroids allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy (except in patients with multiple tumors
who have received radiotherapy to some of their tumors) and recovered

Surgery:

- Recovered from prior surgery

Other:

- No prior antineoplaston therapy

- Prior cytodifferentiating agents allowed