Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of the Esophagus
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Response rate based on tumor measurements taken at 12 weeks
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute
|Houston, Texas 77055-6330