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Sponsored by: |
Burzynski Research Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003536 |
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.
Condition | Intervention | Phase |
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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 II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Randomized Study of Methotrexate With or Without Antineoplaston A10 Capsules in Women With Advanced Breast Cancer |
OBJECTIVES:
OUTLINE: This is a randomized study.
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Texas | |
Burzynski Clinic | |
Houston, Texas, United States, 77055-6330 |
Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
Study ID Numbers: | CDR0000066584, BC-BR-10 |
Study First Received: | November 1, 1999 |
Last Updated: | December 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00003536 History of Changes |
Health Authority: | United States: Federal Government |
Antimetabolites Skin Diseases Immunologic Factors Breast Neoplasms Folate Folic Acid Antagonists Folinic Acid |
Immunosuppressive Agents Vitamin B9 Recurrence Folic Acid Methotrexate Antirheumatic Agents Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Abortifacient Agents Methotrexate Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors Breast Diseases |