Metastatic Renal Cell CarcinomaPhase 2NCT00318110
Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma
A Phase 2 study testing NST using MUD for metastatic renal cell carcinoma in people with Metastatic Renal Cell Carcinoma, run by Center for International Blood and Marrow Transplant Research at 5 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- NST using MUD for metastatic renal cell carcinoma
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2006to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior allogeneic stem cell transplantation
- RCC with histology other than clear cell type
- History or presence of brain metastasis
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Shands - University of Florida
Gainesville, Florida, 32610
M.D. Anderson Cancer Center
Houston, Texas, 77030
University of California - Los Angeles
Los Angeles, California, 90095
University of Minnesota
Minneapolis, Minnesota, 55455
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Multicenter Phase II Study of Non-Myeloablative Allogeneic Stem Cell Transplantation Using Matched Unrelated Donor for Metastatic Renal Cell Carcinoma
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).
Read the 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.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- NST using MUD for metastatic renal cell carcinoma
- Keywords
- Metastatic, Renal, Cell, Carcinoma, Unrelated, Donor, Transplant, stage IV, clear cell
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NST using MUD for metastatic renal cell carcinomaProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| MUD treatment | Experimental | NST using MUD for metastatic renal cell carcinoma Receives: Procedure: NST using MUD for metastatic renal cell carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (6)
Overall survival after MUD NST
Measured: Two years
Rate of complete donor myeloid and lymphoid chimerism after MUD NST
Measured: One year
Incidence and severity of acute and chronic graft-versus-host disease (GvHD) after MUD NST
Measured: Two years
Incidence of treatment-related mortality (TRM)
Measured: 100 Days
Assess cytotoxic T-lymphocyte reactivity
Measured: One year
Assess antibody activity against potential tumor antigenic peptides in graft-versus-renal cell carcinoma (RCC) effect
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Unable to meet subject enrollment goal.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for International Blood and Marrow Transplant Research
- Sponsor type
- Research network
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Naoto Ueno, M.D., Ph.D., Study chair, MDACC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318110
- Sponsor's protocol ID
- T00008
- Status last verified
- Jul 2016
- First submitted
- 24 Apr 2006
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Only 2 subjects enrolled prior to study closure due to slow accrual.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study of Non-Myeloablative Allogeneic Stem Cell Transplantation Using Matched Unrelated Donor for Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00318110
- Acronym / sponsor ID
- T00008
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- Metastatic, Renal, Cell, Carcinoma, Unrelated, Donor, Transplant, stage IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to meet subject enrollment goal.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Center for International Blood and Marrow Transplant ResearchResearch network
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- Apr 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MUD treatment | Experimental | Procedure: NST using MUD for metastatic renal cell carcinomaNST using MUD for metastatic renal cell carcinoma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Prior allogeneic stem cell transplantation
- RCC with histology other than clear cell type
- History or presence of brain metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NST using MUD for metastatic renal cell carcinomaPreparative 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 | Procedure or surgery | MUD treatment |
Primary outcome
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
6 secondary outcomes
Overall survival after MUD NST
Time frame: Two years
Rate of complete donor myeloid and lymphoid chimerism after MUD NST
Time frame: One year
Incidence and severity of acute and chronic graft-versus-host disease (GvHD) after MUD NST
Time frame: Two years
Incidence of treatment-related mortality (TRM)
Time frame: 100 Days
Assess cytotoxic T-lymphocyte reactivity
Time frame: One year
Assess antibody activity against potential tumor antigenic peptides in graft-versus-renal cell carcinoma (RCC) effect
Time frame: Six months
Results and safety
The study was stopped early (reason given: Unable to meet subject enrollment goal.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Click for more information about the Center for International Blood and Marrow Transplant ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: No. Only 2 subjects enrolled prior to study closure due to slow accrual.
Related trials for Metastatic Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naoto Ueno, M.D., Ph.D. study chair
MDACC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NST using MUD for metastatic renal cell carcinoma in people with Metastatic Renal Cell Carcinoma, run by Center for International Blood and Marrow Transplant Research at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to meet subject enrollment goal.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.