Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma

• Sponsor: Center for International Blood and Marrow Transplant Research (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00318110
• Collaborator: M.D. Anderson Cancer Center (Other)
• Enrollment: 4
• Locations: 5
• Arm: 1
• Duration (Months): 35
• Patients Per Site: 0.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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).

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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MUD treatment NST using MUD for metastatic renal cell carcinoma	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

Outcome Measures

Primary Outcome Measures

1. 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

1. Overall survival after MUD NST [Two years]

2. Rate of complete donor myeloid and lymphoid chimerism after MUD NST [One year]

3. Incidence and severity of acute and chronic graft-versus-host disease (GvHD) after MUD NST [Two years]

4. Incidence of treatment-related mortality (TRM) [100 Days]

5. Assess cytotoxic T-lymphocyte reactivity [One year]

6. Assess antibody activity against potential tumor antigenic peptides in graft-versus-renal cell carcinoma (RCC) effect [Six months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of California - Los Angeles	Los Angeles	California	United States	90095
2	Shands - University of Florida	Gainesville	Florida	United States	32610
3	University of Minnesota	Minneapolis	Minnesota	United States	55455
4	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
5	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Center for International Blood and Marrow Transplant Research
• ClinicalTrials.gov Identifier: NCT00318110
• Other Study ID Numbers: T00008; NCT00429130
• First Posted: Apr 26, 2006
• Last Update Posted: Jul 26, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Jul 26, 2016