Clinical Trial: Antineoplaston Therapy in Treating Patients With Recurrent or Stage IV Lung Cancer
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Bronchial Alveolar Carcinoma of the Lung
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 recurrent or stage IV lung cancer.
Detailed Summary:
OBJECTIVES:
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with recurrent or stage IV bronchoalveolar cell lung cancer.
- Describe response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open-label study.
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 3 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.
Tumors are measured 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.
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
