Antineoplaston Therapy in Treating Patients With Primary Liver 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 studies the effectiveness of antineoplaston therapy in treating patients who have primary liver cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Antineoplaston A10 in Patients With Primary Liver Cancer|
|Study Start Date:||August 1998|
- Determine the response, tolerance to, and side effects of antineoplaston A10 in patients with incurable primary liver cancer.
OUTLINE: This is an open label study.
Patients receive gradually increasing doses of antineoplaston A10 by arterial infusion daily until the final dose level is reached.
Therapy continues for at least 2 months in the absence of unacceptable toxicity and disease progression. Patients achieving complete response (CR) continue treatment for an additional 2 months after reaching CR.
Tumors are measured every month for the first 2 months, every 2 months for the first year, and every 3 months for the second year.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003530
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|