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| Tracking Information | |||||
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| First Received Date ICMJE | December 10, 1999 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | September 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Clinical disease-free survival (DFS) [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Clinical disease-free survival (DFS) | ||||
| Change History | Complete list of historical versions of study NCT00004143 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Peripheral Stem Cell Transplant Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma | ||||
| Official Title ICMJE | Allogeneic Mixed Chimerism Stem Cell Transplantation Utilizing In Vivo and In Vitro CAMPATH-1H for High Risk Diseases | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 70 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004143 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067374, DUMC-1340-99-7, NCI-G99-1617 | ||||
| Study Sponsor ICMJE | Duke University | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | November 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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