Recurrent Colon Cancer Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 Capsules in Patients With Adenocarcinoma of the Colon
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.
OBJECTIVES:
- 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.
;
Primary Purpose: Treatment
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