Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma

This study has been terminated.
(Unable to meet subject enrollment goal.)
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by:
Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:
NCT00318110
First received: April 24, 2006
Last updated: September 29, 2008
Last verified: September 2008
  Purpose

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).


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Procedure: NST using MUD for metastatic renal cell carcinoma
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Phase II Study of Non-Myeloablative Allogeneic Stem Cell Transplantation Using Matched Unrelated Donor for Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Center for International Blood and Marrow Transplant Research:

Primary Outcome Measures:
  • 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) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

Enrollment: 4
Study Start Date: April 2006
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318110

Locations
United States, California
University of California - Los Angeles
Los Angeles, California, United States, 90095
United States, Florida
Shands - University of Florida
Gainesville, Florida, United States, 32610
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
M.D. Anderson Cancer Center
Investigators
Study Chair: Naoto Ueno, M.D., Ph.D. MDACC
  More Information

Additional Information:
No publications provided

Responsible Party: Roberta King, MPH VP of CIBMTR, National Marrow Donor Program
ClinicalTrials.gov Identifier: NCT00318110     History of Changes
Obsolete Identifiers: NCT00429130
Other Study ID Numbers: T00008
Study First Received: April 24, 2006
Last Updated: September 29, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Center for International Blood and Marrow Transplant Research:
Metastatic
Renal
Cell
Carcinoma
Unrelated
Donor
Transplant
stage IV
clear cell

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014