Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. It is not yet known whether giving antineoplastons with chemotherapy is more effective than chemotherapy alone in treating women with refractory breast cancer.
PURPOSE: This randomized phase II trial is studying methotrexate alone to see how well it works campared to methotrexate and antineoplaston therapy in treating postmenopausal women with advanced refractory breast cancer.
|Stage IV Breast Cancer Recurrent Breast Cancer||Drug: antineoplaston A10 Drug: methotrexate Procedure: alternative product therapy Procedure: biological therapy Procedure: biologically based therapies Procedure: cancer prevention intervention Procedure: chemotherapy Procedure: complementary and alternative therapy Procedure: differentiation therapy||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003536
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|