Kidney Cancer
Conditions
Keywords
stage IV renal cell cancer, recurrent renal cell cancer
Brief 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).
Detailed 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.
Interventions
BIOLOGICALalemtuzumab
BIOLOGICALgraft-versus-tumor induction therapy
DRUGcyclophosphamide
DRUGfludarabine phosphate
PROCEDUREallogeneic bone marrow transplantation
PROCEDUREperipheral blood stem cell transplantation
Sponsors
Baylor College of Medicine
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with treatment related mortality | 100 |
Countries
United States
Outcome results
None listed