Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Adrenal Gland
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with stage IV adrenal gland carcinoma.
- Determine the tolerance to and side effects of this regimen in these patients.
- Determine the response in patients treated with this regimen.
OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and
antineoplaston AS2-1 IV over a minimum of 1 hour 6 times daily until the maximum tolerated
dose is reached.
Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR.
Patients are followed every 2 months for the first year and then every 3 months for the
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
|Burzynski Clinic||Houston, Texas 77055-6330|