Antineoplaston Therapy in Treating Patients With Colon Cancer
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.
|Stage IV Colon Cancer Recurrent Colon Cancer Adenocarcinoma of the Colon||Drug: antineoplaston A10 Drug: antineoplaston AS2-1 Procedure: alternative product therapy Procedure: biological therapy Procedure: biologically based therapies Procedure: cancer prevention intervention Procedure: complementary and alternative therapy Procedure: differentiation therapy||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 Capsules in Patients With Adenocarcinoma of the Colon|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003486
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|