Clinical trial NCT00318110: Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma
Official title: Multicenter Phase II Study of Non-Myeloablative Allogeneic Stem Cell Transplantation Using Matched Unrelated Donor for Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Metastatic
Renal
Cell
Carcinoma
Unrelated
Donor
Transplant
stage IV
clear cell
Lead sponsor: Center for International Blood and Marrow Transplant Research
Sponsor class: NETWORK
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2006-04-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: 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)
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival after MUD NST
timeFrame: Two years
measure: Rate of complete donor myeloid and lymphoid chimerism after MUD NST
timeFrame: One year
measure: Incidence and severity of acute and chronic graft-versus-host disease (GvHD) after MUD NST
timeFrame: Two years
measure: Incidence of treatment-related mortality (TRM)
timeFrame: 100 Days
measure: Assess cytotoxic T-lymphocyte reactivity
timeFrame: One year
measure: Assess antibody activity against potential tumor antigenic peptides in graft-versus-renal cell carcinoma (RCC) effect
timeFrame: Six months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California - Los Angeles
state: California
city: Gainesville
country: United States
facility: Shands - University of Florida
state: Florida
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: MDACC
name: Naoto Ueno, M.D., Ph.D.
role: STUDY_CHAIR
References: