Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to find out what effects (good and bad) a stem cell transplant from an unrelated donor will have for patients with kidney cancer that has spread to other parts of the body (metastasized).

Detailed Description
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Standard treatment for kidney cancer that has spread to other parts of the body may include immunotherapy (a therapy that uses the body's natural immune system to fight cancer) and cytokines (proteins found in the body). If these treatments are not successful at controlling the cancer then chemotherapy or thalidomide are used. Chemotherapy and thalidomide will not cure kidney cancer but they may control the disease in some patients. In some patients, transplants are now proposed for study. Stem cells (from bone marrow or the bloodstream) are normally used to treat cancers of the blood, not kidney cancer. Since researchers are still learning about using stem cell transplants for kidney cancer, the study is considered a research study. Patients participating in this study will receive smaller doses of chemotherapy drugs to prepare them for the transplant than patients who have a standard transplant. This type of transplant is called a reduced intensity transplant. A reduced intensity transplant uses the cell-killing activity of the transplanted donor stem cells to attack the recipient's cancer cells. This is called graft-versus-tumor-effect (GVT). Previous studies have shown that GVT may be greater if the donor is not related to the recipient.

Official Title
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Multicenter Phase II Study of Non-Myeloablative Allogeneic Stem Cell Transplantation Using Matched Unrelated Donor for Metastatic Renal Cell Carcinoma

Conditions
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Metastatic Renal Cell Carcinoma

Intervention / Treatment
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* Procedure: NST using MUD for metastatic renal cell carcinoma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of metastatic (stage IV) renal cell carcinoma (RCC) predominately clear cell type Prior nephrectomy Available HLA-matched (8/8, 7/8) unrelated donor At least one prior immunotherapy; or immunotherapy + chemotherapy; or targeted therapy, for metastatic RCC. Adequate organ function Exclusion Criteria: Prior allogeneic stem cell transplantation RCC with histology other than clear cell type History or presence of brain metastasis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MUD treatment<br>NST using MUD for metastatic renal cell carcinoma | Procedure: NST using MUD for metastatic renal cell carcinoma<br>* Preparative regimen: Fludarabine 25 mg/m2 IV once a day x 5 days (-6,-5,-4,-3,-2) Melphalan 70 mg/m2 IV once a day x 2 days (-3,-2) Donor Stem Cell Infusion: Stem cells will be infused on day 0 GVHD prophylaxis: Tacrolimus and methotrexate 5 mg/m2 IV day 1, 3, 6 and 11<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the best rate of tumor response of complete response (CR) + complete unconfirmed response (CRU) + partial response (PR) within 6 months after matched unrelated donor (MUD) nonmyeloablative stem cell transplantation (NST) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival after MUD NST |  | Two years | 
| Rate of complete donor myeloid and lymphoid chimerism after MUD NST |  | One year | 
| Incidence and severity of acute and chronic graft-versus-host disease (GvHD) after MUD NST |  | Two years | 
| Incidence of treatment-related mortality (TRM) |  | 100 Days | 
| Assess cytotoxic T-lymphocyte reactivity |  | One year | 
| Assess antibody activity against potential tumor antigenic peptides in graft-versus-renal cell carcinoma (RCC) effect |  | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic, Renal, Cell, Carcinoma, Unrelated, Donor, Transplant, stage IV, clear cell