Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056095
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2003-03-06
Brief Title:
Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic kidney cancer
PURPOSE This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic kidney cancer
Detailed Description:
OBJECTIVES
Determine the 18-month survival rate of patients with metastatic renal cell carcinoma treated with allogeneic stem cell transplantation
Determine the objective rate of response of patients treated with this regimen
Determine post-transplant immunological reactions and recuperation of patients treated with this regimen
Determine the antitumoral activity of this regimen in these patients
OUTLINE This is a non-randomized multicenter study Patients are assigned to 1 of 2 treatment groups based on availability of a compatible family member for stem cell transplantation
Group I Patients with a compatible family donor receive conditioning chemotherapy comprising cyclophosphamide IV over 2 hours on days -7 and -6 and fludarabine IV once daily on days -5 to -1 Patients undergo filgrastim G-CSF-mobilized allogeneic stem cell transplantation on day 0 Patients also receive immunosuppression therapy with cyclosporine beginning on day -2 Patients who have persistent or progressive disease mixed chimerism and no evidence of grade 2 or greater graft-vs-host disease and have been off immunosuppression therapy for 1-2 weeks receive donor lymphocyte infusion on days 7 and 21
Group II Patients without a compatible family donor receive treatment immunotherapy vaccination therapy or chemotherapy at the discretion of the treating physician
Patients are followed every 3 months for 5 years
PROJECTED ACCRUAL A total of 170 patients 60 patients for group I and 110 patients for group II will be accrued for this study within 3 years
Determine the 18-month survival rate of patients with metastatic renal cell carcinoma treated with allogeneic stem cell transplantation
Determine the objective rate of response of patients treated with this regimen
Determine post-transplant immunological reactions and recuperation of patients treated with this regimen
Determine the antitumoral activity of this regimen in these patients
OUTLINE This is a non-randomized multicenter study Patients are assigned to 1 of 2 treatment groups based on availability of a compatible family member for stem cell transplantation
Group I Patients with a compatible family donor receive conditioning chemotherapy comprising cyclophosphamide IV over 2 hours on days -7 and -6 and fludarabine IV once daily on days -5 to -1 Patients undergo filgrastim G-CSF-mobilized allogeneic stem cell transplantation on day 0 Patients also receive immunosuppression therapy with cyclosporine beginning on day -2 Patients who have persistent or progressive disease mixed chimerism and no evidence of grade 2 or greater graft-vs-host disease and have been off immunosuppression therapy for 1-2 weeks receive donor lymphocyte infusion on days 7 and 21
Group II Patients without a compatible family donor receive treatment immunotherapy vaccination therapy or chemotherapy at the discretion of the treating physician
Patients are followed every 3 months for 5 years
PROJECTED ACCRUAL A total of 170 patients 60 patients for group I and 110 patients for group II will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20234 | OTHER | European union | None |
| FRE-FNCLCC-GETUG-110105 | OTHER | None | None |