Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334438
Status:
COMPLETED
Last Update Posted:
2016-12-23
First Post:
2006-06-06
Brief Title:
Bortezomib Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory Low-Grade Follicular or Mantle Cell Non-Hodgkins Lymphoma
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Study Evaluating Combined Zevalin Ibritumomab Tiuxetan and Valcade Bortezomib in RelapsedRefractory Low-Grade or Follicular B-Cell and Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-12
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 Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Monoclonal antibodies such as rituximab and radiolabeled monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan 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 without harming normal cells Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan in treating patients with relapsed or refractory low-grade follicular or mantle cell non-Hodgkins lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan in treating patients with relapsed or refractory low-grade follicular or mantle cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose MTD of bortezomib in combination with rituximab and yttrium Y 90 ibritumomab tiuxetan in patients with relapsed or refractory low-grade follicular B-cell or mantle cell non-Hodgkins lymphoma
Determine the dose-limiting toxicity of this regimen in these patients
Secondary
Determine the response rate in patients treated with this regimen
OUTLINE This is a multicenter open-label nonrandomized dose-escalation study of bortezomib
Patients receive rituximab IV over 4 hours followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 to assess biodistribution Patients without altered biodistribution receive rituximab IV over 4 hours followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8 Patients also receive bortezomib IV over 3-5 seconds on days 4 8 11 and 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 3 or 2 of 6 patients experience dose-limiting toxicity Additional patients may be treated at the MTD
After completion of study treatment patients are followed every 3 months for 18 months and then every 6 months thereafter
Primary
Determine the maximum tolerated dose MTD of bortezomib in combination with rituximab and yttrium Y 90 ibritumomab tiuxetan in patients with relapsed or refractory low-grade follicular B-cell or mantle cell non-Hodgkins lymphoma
Determine the dose-limiting toxicity of this regimen in these patients
Secondary
Determine the response rate in patients treated with this regimen
OUTLINE This is a multicenter open-label nonrandomized dose-escalation study of bortezomib
Patients receive rituximab IV over 4 hours followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 to assess biodistribution Patients without altered biodistribution receive rituximab IV over 4 hours followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8 Patients also receive bortezomib IV over 3-5 seconds on days 4 8 11 and 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 3 or 2 of 6 patients experience dose-limiting toxicity Additional patients may be treated at the MTD
After completion of study treatment patients are followed every 3 months for 18 months and then every 6 months thereafter
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 |
|---|---|---|---|
| CDR0000550130 | OTHER | PDQ number | None |