Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma
NCT ID: NCT00318110
Last Updated: 2016-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2006-04-30
2009-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MUD treatment
NST using MUD for metastatic renal cell carcinoma
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* RCC with histology other than clear cell type
* History or presence of brain metastasis
18 Years
65 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Center for International Blood and Marrow Transplant Research
NETWORK
Responsible Party
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Principal Investigators
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Naoto Ueno, M.D., Ph.D.
Role: STUDY_CHAIR
MDACC
Locations
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University of California - Los Angeles
Los Angeles, California, United States
Shands - University of Florida
Gainesville, Florida, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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Click for more information about the Center for International Blood and Marrow Transplant Research
Other Identifiers
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T00008
Identifier Type: -
Identifier Source: org_study_id
NCT00429130
Identifier Type: -
Identifier Source: nct_alias
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