Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Head and Neck
- Provide treatment with antineoplastons A10 and AS2-1 to patients with incurable cancer
of the head and neck.
- 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 six times per day until the maximum tolerated dose is reached.
Treatment continues for at least 2 months in the absence of disease progression or
unacceptable toxicity. After 2 months, patients with stable or responding disease may
continue treatment. Patients achieving complete response (CR) continue treatment for 8
months beyond CR.
Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute
United States: Federal Government
|Houston, Texas 77055-6330