Kidney Cancer Clinical Trial
Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation
Summary
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).
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Houston Texas, 77030, United States
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