Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma

Metastatic Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00318110
• Other study ID #: T00008
• Status: Terminated
• Phase: Phase 2
• First received: April 24, 2006
• Last updated: July 25, 2016
• Start date: April 2006
• Est. completion date: March 2009

Study information

• Verified date: July 2016
• Source: Center for International Blood and Marrow Transplant Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Other known NCT identifiers

• NCT00429130

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Procedure:
• NST using MUD for metastatic renal cell carcinoma
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

Locations

Country	Name	City	State
United States	Shands - University of Florida	Gainesville	Florida
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	University of California - Los Angeles	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Center for International Blood and Marrow Transplant Research	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Click for more information about the Center for International Blood and Marrow Transplant Research