Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma
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 advanced mesothelioma.
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Mesothelioma|
- Response rate based on tumor measurements taken at 12 weeks
- Survival at 1, 2, and 5 years from the start of treatment
|Study Start Date:||March 1996|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- Provide treatment with antineoplastons A10 and AS2-1 to patients with stage IV mesothelioma.
- Describe the response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 IV six times per day until the maximum dose is reached.
Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. After 3 months, patients with stable or responding disease may continue treatment. Patients achieving complete response (CR) continue treatment for at least 8 months beyond CR.
Patients are followed every 2 months for 1 year and then every 3 months for the second year.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003508
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|