Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma

Center for International Blood and Marrow Transplant Research (CIBMTR)

Status and phase: Terminated; Phase 2

Conditions: Metastatic Renal Cell Carcinoma

Treatments: Procedure: NST using MUD for metastatic renal cell carcinoma

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00318110

T00008

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

4 participants in 1 patient group

MUD treatment

Experimental group

Description:

NST using MUD for metastatic renal cell carcinoma

Treatment:

Procedure: NST using MUD for metastatic renal cell carcinoma