Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation
NCT ID: NCT00073879
Last Updated: 2015-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
2003-04-30
2004-04-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining fludarabine and cyclophosphamide with alemtuzumab in treating patients who are undergoing allogeneic stem cell transplantation for recurrent or metastatic renal cell carcinoma (kidney cancer).
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Detailed Description
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* Determine the safety and feasibility of fludarabine, cyclophosphamide, and alemtuzumab in patients with recurrent or metastatic renal cell carcinoma undergoing HLA-matched allogeneic stem cell transplantation.
OUTLINE: This is a pilot, multicenter study.
* Conditioning: Patients receive fludarabine IV over 30 minutes on days -6 to -2, cyclophosphamide IV over 2 hours on days -6 and -5, and alemtuzumab IV on days -4 to -2.
* Allogeneic transplantation: Allogeneic stem cells are infused on day 0. Patients receive graft-vs-host disease prophylaxis with tacrolimus IV or orally for approximately 30 days.
Patients are followed weekly for 100 days and then at 6, 12, 18, 24, 36, 48, and 60 months after transplantation.
PROJECTED ACCRUAL: A total of 20 patients (10 with HLA-identical related donors and 10 with matched unrelated donors) will be accrued for this study.
Conditions
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Study Design
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TREATMENT
Interventions
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alemtuzumab
graft-versus-tumor induction therapy
cyclophosphamide
fludarabine phosphate
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of recurrent or metastatic renal cell carcinoma
* Failed interleukin-2 (IL-2)-based therapy OR intolerant to IL-2
* Clinically evident and followable disease
* Availability of 1 of the following compatible donors:
* Related HLA-identical or 1-Ag mismatched donor
* Unrelated HLA-A, B, DRB1-matched donor
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* Karnofsky 70-100%
Life expectancy
* No concurrent illness that severely limits life expectancy
Hematopoietic
* Not specified
Hepatic
* No episode of hepatitis within the past month
* No evidence of chronic active hepatitis or cirrhosis
Renal
* Creatinine no greater than 2 mg/dL
Cardiovascular
* LVEF at least 40%
* No uncontrolled arrhythmias
* No symptomatic cardiac disease
Pulmonary
* FEV\_1, FVC, and DLCO at least 50% of predicted (unless due to metastatic disease)
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* No active infection
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
ALL
No
Sponsors
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Baylor College of Medicine
OTHER
Responsible Party
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Helen Heslop
Professor
Principal Investigators
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Uday Popat, MD
Role: STUDY_CHAIR
Baylor College of Medicine
Locations
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Baylor College of Medicine
Houston, Texas, United States
Countries
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Other Identifiers
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BCM-H-8447
Identifier Type: -
Identifier Source: secondary_id
CDR0000328247
Identifier Type: -
Identifier Source: org_study_id
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