Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070447
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2003-10-03
Brief Title:
Rituximab Prednisone Cyclophosphamide Doxorubicin Vincristine and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Rituximab NSC 687451 CHOP Followed by 90Y-Ibritumomab Tiuxetan NSC 710085 in Patients With Previously Untreated Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2004-10
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 Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells Drugs used in chemotherapy such as prednisone cyclophosphamide doxorubicin and vincristine use different ways to stop cancer cells from dividing so they stop growing or die Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells
PURPOSE This phase II trial is studying how well giving rituximab and combination chemotherapy together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with previously untreated mantle cell lymphoma
PURPOSE This phase II trial is studying how well giving rituximab and combination chemotherapy together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with previously untreated mantle cell lymphoma
Detailed Description:
OBJECTIVES
Determine the time to treatment failure in patients with previously untreated mantle cell lymphoma treated with rituximab and CHOP chemotherapy comprising prednisone cyclophosphamide doxorubicin and vincristine followed by yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8 yttrium Y 90 Zevalin
Determine the response rate in patients at the completion of rituximab and CHOP and the incremental response rate after IDEC-Y2B8
Determine the toxicity of this regimen in these patients
Correlate serum rituximab levels with response in patients treated with this regimen
OUTLINE This is a multicenter study
CHOP chemotherapy and rituximab Patients receive cyclophosphamide IV doxorubicin IV vincristine IV and rituximab IV on day 1 and oral prednisone on days 1-5 R CHOP Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients who have responding or stable disease proceed to radioimmunotherapy
Radioimmunotherapy Within 4-7 weeks after the completion of R CHOP chemotherapy patients receive rituximab IV and an imaging dose of indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 Patients then undergo whole body gamma imaging scans during the first day 2-24 hours and the second or third day 48-72 hours after injection In the absence of altered biodistribution patients receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8 yttrium Y 90 Zevalin IV over 10 minutes on day 8
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 57 patients will be accrued for this study within 28 years
Determine the time to treatment failure in patients with previously untreated mantle cell lymphoma treated with rituximab and CHOP chemotherapy comprising prednisone cyclophosphamide doxorubicin and vincristine followed by yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8 yttrium Y 90 Zevalin
Determine the response rate in patients at the completion of rituximab and CHOP and the incremental response rate after IDEC-Y2B8
Determine the toxicity of this regimen in these patients
Correlate serum rituximab levels with response in patients treated with this regimen
OUTLINE This is a multicenter study
CHOP chemotherapy and rituximab Patients receive cyclophosphamide IV doxorubicin IV vincristine IV and rituximab IV on day 1 and oral prednisone on days 1-5 R CHOP Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients who have responding or stable disease proceed to radioimmunotherapy
Radioimmunotherapy Within 4-7 weeks after the completion of R CHOP chemotherapy patients receive rituximab IV and an imaging dose of indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 Patients then undergo whole body gamma imaging scans during the first day 2-24 hours and the second or third day 48-72 hours after injection In the absence of altered biodistribution patients receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8 yttrium Y 90 Zevalin IV over 10 minutes on day 8
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 57 patients will be accrued for this study within 28 years
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 |
|---|---|---|---|
| ECOG-E1499 | None | None | None |