Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058292
Status:
COMPLETED
Last Update Posted:
2012-06-01
First Post:
2003-04-07
Brief Title:
Radiolabeled Monoclonal Antibody Therapy and High-Dose Chemotherapy Followed By Autologous Peripheral Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase I Trial Combining IDEC-Y2B8 And High-Dose Beam Chemotherapy With Hematopoietic Progenitor Cell Transplant In Patients With Relapsed Or Refractory B-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-05
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 Radiolabeled monoclonal antibodies such as yttrium Y90 ibritumomab tiuxetan can locate cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining yttrium Y90 ibritumomab tiuxetan and chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE This phase I trial is studying how well giving yttrium Y90 ibritumomab tiuxetan with high-dose chemotherapy followed by autologous stem cell transplant work in treating patients with relapsed or refractory non-Hodgkins lymphoma
PURPOSE This phase I trial is studying how well giving yttrium Y90 ibritumomab tiuxetan with high-dose chemotherapy followed by autologous stem cell transplant work in treating patients with relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan in terms of absorbed radiation to critical organs when administered with high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation in patients with relapsed or refractory B-cell non-Hodgkins lymphoma
Determine whether the residual radioactivity detected at the time of stem cell reinfusion affects the reinfused cells and delays engraftment in patients treated with this regimen
Determine the duration of response and survival of patients treated with this regimen
OUTLINE This is a dose-escalation study of yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8
Radioimmunotherapy Patients receive rituximab IV followed by indium In 111 ibritumomab tiuxetan for imaging IV over 10 minutes on day -22 Patients then receive rituximab IV and IDEC-Y2B8 IV over 10 minutes on day -14
Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity
High-dose conditioning regimen Patients receive BEAM chemotherapy comprising carmustine IV over 2 hours on day -6 etoposide IV over 2 hours twice daily and cytarabine IV over 1 hour twice daily on days -5 to -2 and melphalan IV over 1 hour on day -1
Autologous stem cell transplantation Autologous peripheral blood stem cells are reinfused on day 0 Patients receive filgrastim G-CSF subcutaneously daily beginning on day 0 and continuing until blood counts recover
Patients are followed at 30 days 3 and 6 months and then annually for 5 years
PROJECTED ACCRUAL A maximum of 42 patients will be accrued for this study
Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan in terms of absorbed radiation to critical organs when administered with high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation in patients with relapsed or refractory B-cell non-Hodgkins lymphoma
Determine whether the residual radioactivity detected at the time of stem cell reinfusion affects the reinfused cells and delays engraftment in patients treated with this regimen
Determine the duration of response and survival of patients treated with this regimen
OUTLINE This is a dose-escalation study of yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8
Radioimmunotherapy Patients receive rituximab IV followed by indium In 111 ibritumomab tiuxetan for imaging IV over 10 minutes on day -22 Patients then receive rituximab IV and IDEC-Y2B8 IV over 10 minutes on day -14
Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity
High-dose conditioning regimen Patients receive BEAM chemotherapy comprising carmustine IV over 2 hours on day -6 etoposide IV over 2 hours twice daily and cytarabine IV over 1 hour twice daily on days -5 to -2 and melphalan IV over 1 hour on day -1
Autologous stem cell transplantation Autologous peripheral blood stem cells are reinfused on day 0 Patients receive filgrastim G-CSF subcutaneously daily beginning on day 0 and continuing until blood counts recover
Patients are followed at 30 days 3 and 6 months and then annually for 5 years
PROJECTED ACCRUAL A maximum of 42 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| IDEC-NU99H11 | None | None | None |
| NU-99H11 | None | None | None |