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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004143 |
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a monoclonal antibody, alemtuzumab, at the time of transplant may stop this from happening.
PURPOSE: This phase II trial is studying peripheral stem cell transplant and monoclonal antibody therapy to see how well they work in treating patients with high-risk hematologic cancer, refractory breast or kidney cancer, or melanoma.
Condition | Intervention | Phase |
Breast Cancer Chronic Myeloproliferative Disorders Kidney Cancer Leukemia Melanoma (Skin) Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: alemtuzumab Drug: cyclophosphamide Drug: filgrastim Drug: fludarabine phosphate Procedure: in vitro-treated peripheral blood stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
Genetics Home Reference related topics: | aceruloplasminemia breast cancer hemophilia |
MedlinePlus related topics: | Breast Cancer Cancer Kidney Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Melanoma Multiple Myeloma |
ChemIDplus related topics: | Cyclophosphamide Filgrastim Fludarabine Fludarabine monophosphate Alemtuzumab Campath |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Allogeneic Mixed Chimerism Stem Cell Transplantation Utilizing In Vivo and In Vitro CAMPATH-1H for High Risk Diseases |
Estimated Enrollment: | 70 |
Study Start Date: | September 1999 |
OBJECTIVES:
OUTLINE: Patients receive alemtuzumab (monoclonal antibody CD52; Campath-1H) IV over 3 hours on days -6 to -2 and fludarabine IV over 30 minutes and cyclophosphamide IV over 1 hour on days -5 to -2. Allogeneic peripheral blood stem cells and alemtuzumab are infused on days 0 and 1. Filgrastim (G-CSF) is administered subcutaneously beginning on day 1 and continuing until blood counts recover.
Patients are followed daily until day 60, twice a week until day 100, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of any one of the following:
Relapsed or refractory hematologic malignancy
Bone marrow failure
Myelofibrosis or paroxysmal nocturnal hemoglobinuria
Visceral organ damage due to disease
Hemoglobinopathies
Solid tumor with metastatic disease and failed at least 1 standard regimen
Breast cancer
Renal cell cancer
Melanoma
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, Florida | |||||
Florida Hospital Cancer Institute | |||||
Orlando, Florida, United States, 32804 | |||||
United States, North Carolina | |||||
Duke Comprehensive Cancer Center | |||||
Durham, North Carolina, United States, 27710 |
Duke University |
National Cancer Institute (NCI) |
Study Chair: | David A. Rizzieri, MD | Duke University |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000067374, DUMC-1340-99-7, NCI-G99-1617 |
First Received: | December 10, 1999 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004143 |
Health Authority: | United States: Federal Government |
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