Antineoplaston Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
Recruitment status was: Active, not recruiting
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 capsules in treating patients who have stage IV non-small cell lung cancer.
|Lung Cancer||Drug: antineoplaston A10 Drug: antineoplaston AS2-1||Phase 2|
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 Capsules In Patients With Non Small Cell Lung Cancer|
|Study Start Date:||August 1998|
- Demonstrate the antitumor activity of antineoplaston A10 and AS2-1 capsules in patients with non-small cell lung cancer 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 antineoplaston A10 and AS2-1 capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity.
Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003497
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|