Antineoplaston Therapy in Treating Patients With Advanced Head and Neck 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 therapy in treating patients who have advanced head and neck cancer.
Head and Neck Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Head and Neck|
|Study Start Date:||August 1998|
- 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.
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|