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Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma
This study is currently recruiting patients.
Sponsored by: | Duke Comprehensive Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Peripheral stem cell transplantation replaces immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Treatment of the cells with a monoclonal antibody may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus monoclonal antibody therapy in treating patients who have high-risk hematologic cancer, refractory breast or kidney cancer, or melanoma.
Condition | Treatment or Intervention | Phase |
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Breast Cancer hematopoietic and lymphoid cancer kidney and urinary cancer skin tumor |
Drug: alemtuzumab Drug: cyclophosphamide Drug: filgrastim Drug: fludarabine Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: bone marrow ablation with stem cell support Procedure: chemotherapy Procedure: colony-stimulating factor therapy Procedure: cytokine therapy Procedure: in vitro-treated peripheral blood stem cell transplantation Procedure: monoclonal antibody therapy Procedure: peripheral blood stem cell transplantation |
Phase II |
MedlinePlus related topics: Blood and Blood Disorders; Breast Cancer; Cancer; Cancer Alternative Therapy; Skin Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Allogeneic Mixed Chimerism Peripheral Blood Stem Cell Transplantation Utilizing In Vivo and In Vitro Alemtuzumab (Monoclonal Antibody CD52; Campath-1H) in Patients With High-Risk Hematologic Malignancies or Refractory Breast or Renal Cell Cancer or Melanoma
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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:
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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