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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020176 |
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of allogeneic peripheral stem cell transplantation in treating patients who have stage IV breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Allogeneic Breast Protocol 1: T-Cell Depleted Allogeneic Blood Stem Cell Transplantation Using an Immunoablative Conditioning Regimen in Metastatic Breast Cancer |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: Patients receive chemotherapy comprising fludarabine IV over 30 minutes and cyclophosphamide IV over 1 hour on days 1-4. Patients receive filgrastim (G-CSF) SC daily beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days for a maximum of 2 courses.
Patients receive a transplantation preparative regimen comprising fludarabine IV over 30 minutes and cyclophosphamide IV over 2 hours on days -6 to -3 (beginning on day 22 of immune-depleting chemotherapy) followed by allogeneic peripheral blood stem cell transplantation IV on day 0. Patients receive G-CSF SC daily beginning on day 0 and continuing until blood counts recover, plus cyclosporine IV over 1-2 hours every 12 hours on days -1 to 14 and then orally until day 40.
Patients with persistent malignant disease and less than grade II acute graft-versus-host disease receive donor lymphocytes IV on days 42, 70, and 98.
Patients are followed twice weekly until day 100, and then at 6, 9, 12, 18, and 24 months.
PROJECTED ACCRUAL: A maximum of 70 patients will be accrued for this study within 24 months.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Progressive disease
At least one prior chemotherapy regimen for metastatic disease and progressed
Hormone receptor status:
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:
United States, Maryland | |
NCI - Center for Cancer Research | |
Bethesda, Maryland, United States, 20892 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Michael R. Bishop, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000067899, NCI-00-C-0119, NCI-1027 |
Study First Received: | July 11, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00020176 History of Changes |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer male breast cancer |
Antimetabolites Anti-Infective Agents Cyclosporine Skin Diseases Immunologic Factors Breast Neoplasms Breast Cancer, Male Cyclophosphamide Fludarabine monophosphate Cyclosporins |
Immunosuppressive Agents Recurrence Breast Neoplasms, Male Antifungal Agents Antineoplastic Agents, Alkylating Fludarabine Antirheumatic Agents Alkylating Agents Breast Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Cyclosporins Neoplasms by Site Therapeutic Uses Antifungal Agents Alkylating Agents |
Dermatologic Agents Breast Diseases Skin Diseases Breast Neoplasms Enzyme Inhibitors Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Fludarabine Antineoplastic Agents, Alkylating Antirheumatic Agents |