Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus
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 cancer of the esophagus.
|Esophageal Cancer||Drug: antineoplaston A10 Drug: antineoplaston AS2-1||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of the Esophagus|
- 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:||May 1996|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- Provide antineoplastons A10 and AS2-1 as treatment for patients with incurable adenocarcinoma of the esophagus.
- Describe the 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 2 months in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) continue treatment for at least 8 months beyond CR. Patients achieving a partial response or stable disease continue treatment until disease progression.
Tumors are measured 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: NCT00003487
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|