Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells can reject the body's normal tissues. Alemtuzumab and tacrolimus may prevent this from happening. 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).

Detailed Description
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OBJECTIVES: 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.

Official Title
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Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma

Conditions
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Kidney Cancer

Intervention / Treatment
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* Biological: alemtuzumab
* Biological: graft-versus-tumor induction therapy
* Drug: cyclophosphamide
* Drug: fludarabine phosphate
* Procedure: allogeneic bone marrow transplantation
* Procedure: peripheral blood stem cell transplantation


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: alemtuzumab|nan|
|Biological: graft-versus-tumor induction therapy|nan|
|Drug: cyclophosphamide|nan|
|Drug: fludarabine phosphate|nan|
|Procedure: allogeneic bone marrow transplantation|nan|
|Procedure: peripheral blood stem cell transplantation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment related mortality |  | 100 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV renal cell cancer, recurrent renal cell cancer