Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372905
Status:
TERMINATED
Last Update Posted:
2019-09-04
First Post:
2006-09-06
Brief Title:
Phase III Trial of VELCADE Plus Zevalin in Patients With Relapsed or Refractory Follicular Lymphoma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase III Trial of Combined Weekly Bortezomib VELCADE and Y-90-Ibritumomab Tiuxetan Zevalin in Patients With Relapsed or Refractory Follicular Lymphoma and Transformed Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was closed permanently before the accrual goal was met due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Radiolabeled monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan can find cancer cells and carry cancer-killing substances to them without harming normal cells Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells
This phase III trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with relapsed or refractory follicular non-Hodgkins lymphoma
This phase III trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with relapsed or refractory follicular non-Hodgkins lymphoma
Detailed Description:
This is a phase I dose-escalation study of bortezomib followed by a phase II study
Phase I
- Induction therapy Patients receive bortezomib IV over 3-5 seconds on days 1 8 15 and 22 rituximab IV on days 8 and 15 and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 15
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
- Consolidation therapy Beginning 6-7 weeks after completing induction therapy patients receive bortezomib IV over 3-5 seconds on days 1 8 and 15 Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity
Phase II Patients receive induction therapy and consolidation therapy as in phase I with bortezomib administered at the MTD determined in phase I
After completion of study treatment patients are followed every 3 months for 1 year every 6 months for 1 year and then annually thereafter
A total of 24 patients will be accrued for this study
Phase I
- Induction therapy Patients receive bortezomib IV over 3-5 seconds on days 1 8 15 and 22 rituximab IV on days 8 and 15 and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 15
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
- Consolidation therapy Beginning 6-7 weeks after completing induction therapy patients receive bortezomib IV over 3-5 seconds on days 1 8 and 15 Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity
Phase II Patients receive induction therapy and consolidation therapy as in phase I with bortezomib administered at the MTD determined in phase I
After completion of study treatment patients are followed every 3 months for 1 year every 6 months for 1 year and then annually thereafter
A total of 24 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 |
|---|---|---|---|
| STU00004871 | OTHER | Northwestern University IRB | None |