Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006968
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2000-12-06
Brief Title:
Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Non-Myeloablative Chemotherapy Followed By Related Allogeneic Stem Cell Rescue In Patients With Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-01
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 tumor cells from dividing so they stop growing or die Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of pentostatin followed by peripheral stem cell transplantation in treating patients who have advanced kidney cancer
PURPOSE Phase III trial to study the effectiveness of pentostatin followed by peripheral stem cell transplantation in treating patients who have advanced kidney cancer
Detailed Description:
OBJECTIVES
Determine the duration and efficiency of hematopoietic and immunologic engraftment in patients with advanced renal cell carcinoma treated with pentostatin followed by related allogeneic stem cell transplantation
Determine the hematologic and non-hematologic toxic effects of this regimen in these patients
Determine the incidence and severity of graft-versus-host disease in patients treated with this regimen
OUTLINE This is a dose-escalation study of pentostatin
Phase I Patients receive pentostatin IV on days -7 -5 and -3 followed by allogeneic stem cell transplantation on day 0 Beginning on day 1 patients receive filgrastim G-CSF IV over 1 hour or subcutaneously daily until blood counts recover As graft-versus-host disease prophylaxis patients receive cyclosporine IV continuously until stem cell engraftment and then orally with gradual tapering
Cohorts of 3 to 6 patients receive escalating doses of pentostatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive treatment as in phase I at the MTD for pentostatin Patients are followed weekly for 60 days and then monthly for 10 months
PROJECTED ACCRUAL A total of 24 patients 12 per phase will be accrued for this study
Determine the duration and efficiency of hematopoietic and immunologic engraftment in patients with advanced renal cell carcinoma treated with pentostatin followed by related allogeneic stem cell transplantation
Determine the hematologic and non-hematologic toxic effects of this regimen in these patients
Determine the incidence and severity of graft-versus-host disease in patients treated with this regimen
OUTLINE This is a dose-escalation study of pentostatin
Phase I Patients receive pentostatin IV on days -7 -5 and -3 followed by allogeneic stem cell transplantation on day 0 Beginning on day 1 patients receive filgrastim G-CSF IV over 1 hour or subcutaneously daily until blood counts recover As graft-versus-host disease prophylaxis patients receive cyclosporine IV continuously until stem cell engraftment and then orally with gradual tapering
Cohorts of 3 to 6 patients receive escalating doses of pentostatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive treatment as in phase I at the MTD for pentostatin Patients are followed weekly for 60 days and then monthly for 10 months
PROJECTED ACCRUAL A total of 24 patients 12 per phase will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1879 | None | None | None |
| UCLA-0001032 | None | None | None |
| SUPERGEN-UCLA-000103201 | None | None | None |