Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Malignant Melanoma
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with progressive or recurrent stage IV melanoma.
- Describe response, 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 3 months in the absence of toxicity and disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR.
Tumors are measured every 2 months for the first year and every 3 months for the second
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Response rate based on tumor measurements at 12 weeks
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute
United States: Federal Government
|Burzynski Clinic||Houston, Texas 77055-6330|