Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Adenocarcinoma of the Colon
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 response to, tolerance to, and side effects of this regimen in these
patients.
OUTLINE: 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 12 months in the absence of disease
progression. Patients achieving complete response (CR) continue treatment for at least 8
months after reaching CR.
Tumors are measured at least every 2 months for 1 year and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Stanislaw R. Burzynski, MD, PhD
Study Chair
Burzynski Research Institute
United States: Federal Government
CDR0000066523
NCT00003485
August 1998
Name | Location |
---|---|
Burzynski Clinic | Houston, Texas 77055-6330 |