Phase II Randomized Study of Methotrexate With or Without Antineoplaston A10 Capsules in Women With Advanced Breast Cancer
- Compare the antitumor activity of antineoplaston A10 with methotrexate vs methotrexate
alone, in terms of objective tumor response, in women with advanced breast cancer.
- Compare the adverse effects of and tolerance to these regimens in these patients.
OUTLINE: This is a randomized study.
- Arm I: Patients receive gradually escalating doses of oral antineoplaston A10 capsules
7 times daily until the maximum tolerated dose is reached, followed by oral
methotrexate capsules 2 to 3 times per day in five days on and five days off courses.
Treatment continues in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral methotrexate alone on the same schedule as in arm I.
Tumors are measured every 4 months for 2 years, every 6 months for years 3 and 4, and then
annually for years 5 and 6.
PROJECTED ACCRUAL: A total of 30-70 patients will be accrued for this study within at least
Primary Purpose: Treatment
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute
United States: Federal Government
|Burzynski Clinic||Houston, Texas 77055-6330|