Donor Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Relapsed or Refractory Metastatic Kidney Cancer

Study Overview
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Brief Summary
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RATIONALE: A peripheral stem cell transplant or bone marrow transplant from a brother or sister may be an effective treatment for kidney cancer. PURPOSE: This phase II trial is studying how well a donor peripheral stem cell or bone marrow transplant works in treating patients with relapsed or refractory metastatic kidney cancer.

Detailed Description
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OBJECTIVES: Determine the efficacy of nonmyeloablative sibling allogeneic peripheral blood stem cell transplantation in patients with relapsed or refractory metastatic renal cell carcinoma. Determine the toxic effects of this regimen in these patients. OUTLINE: This is a pilot study. Conditioning regimen: Patients receive cyclophosphamide IV on days -7 and -6 and fludarabine IV on days -5 to -1. Patients receiving 5/6-mismatched cells also receive anti-thymocyte globulin IV on days -5 to -3. Allogeneic peripheral blood stem cell (PBSC) infusion: Patients undergo allogeneic PBSC or bone marrow transplantation on day 0. Graft-versus-host disease (GVHD) prophylaxis: Patients receive oral mycophenolate mofetil twice daily on days 0-30. Patients receive tacrolimus IV continuously or orally twice daily beginning on day -2 and continuing up to day 44-100 in the absence of GVHD. Donor lymphocyte infusion: Patients with partial or complete T-cell chimerism receive up to 3 donor lymphocyte infusions in the absence of GVHD or progressive disease. After completion of study treatment, patients are evaluated periodically for 3 years. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Official Title
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Non-Myeloablative HLA-Matched Sibling Allogeneic Peripheral Blood Stem Cell Transplantation for Metastatic Renal Cell Carcinoma

Conditions
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Kidney Cancer

Intervention / Treatment
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* Biological: anti-thymocyte globulin
* Biological: graft-versus-tumor induction therapy
* Biological: therapeutic allogeneic lymphocytes
* Drug: cyclophosphamide
* Drug: fludarabine phosphate
* Drug: mycophenolate mofetil
* Drug: tacrolimus
* 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: Histologically confirmed metastatic renal cell carcinoma Relapsed or refractory disease Tumor not amenable to complete surgical resection No bone metastases only No untreated brain metastases Measurable disease Available sibling donor who is HLA-identical or who has a mismatch at a single HLA locus (i.e., a 6/6 or 5/6 match at the HLA-A, -B, and -DR loci) PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin < 3 mg/dL Renal Creatinine < 2 mg/dL No untreated hypercalcemia Cardiovascular LVEF ≥ 40% Pulmonary DLCO ≥ 40% Other Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test HIV-1 and -2 negative No uncontrolled infection No other active malignancy except basal skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: At least 15 days since prior treatment for renal cell carcinoma No other concurrent anticancer therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: anti-thymocyte globulin|nan|
|Biological: graft-versus-tumor induction therapy|nan|
|Biological: therapeutic allogeneic lymphocytes|nan|
|Drug: cyclophosphamide|nan|
|Drug: fludarabine phosphate|nan|
|Drug: mycophenolate mofetil|nan|
|Drug: tacrolimus|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 |
| --- | --- | --- |
| Response rate based on tumor measurements at 1 year |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity as measured by NCI CTC at days 0, 7, 14, 21 and 28 after transplantation and monthly for 11 months |  |  | 
| Overall and disease-free survival at day 100 and 1 year after transplantation |  |  | 

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