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Sponsored by: |
National Cancer Institute (NCI) |
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 |
Breast Cancer |
Drug: cyclophosphamide Drug: cyclosporine Drug: filgrastim Drug: fludarabine phosphate Drug: therapeutic allogeneic lymphocytes Procedure: peripheral blood stem cell transplantation |
Phase II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Cyclophosphamide Filgrastim Fludarabine Fludarabine monophosphate Cyclosporine Cyclosporin |
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) |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Bishop MR, Fowler DH, Marchigiani D, Castro K, Kasten-Sportes C, Steinberg SM, Gea-Banacloche JC, Dean R, Chow CK, Carter C, Read EJ, Leitman S, Gress R. Allogeneic lymphocytes induce tumor regression of advanced metastatic breast cancer. J Clin Oncol. 2004 Oct 1;22(19):3886-92. Epub 2004 Aug 16.
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Bishop MR, Steinberg SM, Gress RE, Hardy NM, Marchigiani D, Kasten-Sportes C, Dean R, Pavletic SZ, Gea-Banacloche J, Castro K, Hakim F, Krumlauf M, Read EJ, Carter C, Leitman SF, Fowler DH. Targeted pretransplant host lymphocyte depletion prior to T-cell depleted reduced-intensity allogeneic stem cell transplantation. Br J Haematol. 2004 Sep;126(6):837-43.
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Bishop MR, Kasten-Sportes C, Dean R, et al.: Preemptive DLI after T cell-depleted reduced-intensity allogeneic HSCT for metastatic breast cancer: effect on engraftment, GVHD, and anti-tumor response. [Abstract] Blood 102 (11): A- 5567, 2003.
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Bishop MR, Marchigiani D, Grasmeder S, et al.: Demonstration of clinical responses to adoptive cellular therapy using allogeneic T cells in metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-657, 2003.
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Bishop MR, Marchigiani D, Odom J, et al.: Contribution of T cells to engraftment: a comparison of T cell depleted vs. T cell replete allografts after reduced-intensity conditioning. [Abstract] Blood 102 (11): A-2447, 2003.
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Study ID Numbers: | CDR0000067899, NCI-00-C-0119, NCI-1027 |
First Received: | July 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00020176 |
Health Authority: | United States: Federal Government |
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