Clinical Trial: Antineoplaston Therapy in Treating Patients With Primary Liver Cancer
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase II Study of Antineoplaston A10 in Patients With Primary Liver Cancer
Brief Summary:
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.
Detailed Summary:
OBJECTIVES:
- 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.
Sponsor: Burzynski Research Institute
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: November 1, 1999
Date Started: August 1998
Date Completion:
Last Updated: July 23, 2008
Last Verified: April 2004
