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 colon cancer.
- Determine the antitumor activity of antineoplastons A10 and AS2-1 in patients with
adenocarcinoma of the colon by determining the proportion of patients who experience an
objective tumor response.
- Evaluate the adverse effects of and tolerance to this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of oral antineoplaston A10 and oral
antineoplaston AS2-1 6-7 times a day. If the patient has not achieved a partial or complete
response after 3-4 months of treatment, the investigator may discontinue treatment. Patients
with stable disease may continue to receive treatment until disease progression or
unacceptable toxicity is observed.
Tumors are measured every 4 months during the first 2 years, then every 6 months during
years 3 and 4, and yearly during years 5 and 6.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
- Histologically confirmed adenocarcinoma of the colon that is unlikely to respond to
existing therapy and for which no curative therapy exists
- Measurable disease by MRI or CT scan
- Metastatic or unresectable disease
- 18 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/SGPT no greater than 5 times upper limit of normal
- No hepatic failure
- Creatinine no greater than 2.5 mg/dL
- No renal failure
- No chronic heart failure
- No uncontrolled hypertension
- No serious lung disease, such as 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 serious malabsorption syndromes
- No other serious concurrent disease
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 corticosteroids allowed
- At least 8 weeks since prior radiotherapy and recovered (patients with multiple
tumors may be admitted earlier)
- No prior extensive stomach or intestinal surgery
- Prior cytodifferentiating agent allowed
- No prior antineoplaston therapy
- No other concurrent anticancer therapy