Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088881
Status:
TERMINATED
Last Update Posted:
2017-05-25
First Post:
2004-08-04
Brief Title:
Rituximab Combination Chemotherapy and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of R-CHOP Followed by Zevalin Radioimmunotherapy for Patients With Previously Untreated Stages I and II CD20 Diffuse Large Cell Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2017-04
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:
This phase II trial is studying how well giving rituximab together with combination chemotherapy and 90-Yttrium ibritumomab tiuxetan works in treating patients with stage I or stage II lymphoma Drugs used in chemotherapy such as prednisone cyclophosphamide doxorubicin and vincristine work in different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as rituximab and yttrium 90-Yttrium ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells Combining a monoclonal antibody with combination chemotherapy and a radiolabeled monoclonal antibody may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the complete response rate CR and functional CR rate in patients with previously untreated stage I with at least 1 risk factor or stage II CD20 diffuse large cell lymphoma who receive therapy with R-CHOP followed by 90-Yttrium -Zevalin
SECONDARY OBJECTIVES
I To evaluate the time to treatment failure duration of response and overall survival in these patients who receive therapy with R-CHOP followed by 90-Yttrium -Zevalin
II To evaluate the toxicity of this therapy III To evaluate the toxicity of adding involved field radiation therapy 12 weeks after Zevalin for patients with CTPET residual masses
TERTIARY OBJECTIVES
I To evaluate PET scans pre -and post - R-CHOPZevalin therapy
OUTLINE
R-CHOP rituximab prednisone cyclophosphamide doxorubicinvincristine Patients receive oral prednisone once daily on days 1-5 Patients also receive rituximab IV over several hours followed by cyclophosphamide IV doxorubicin IV and vincristine IV over 30-60 minutes on day 1 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR after 2 courses receive 2 additional courses Patients achieving a partial response uncertain CR or stable disease receive 4 additional courses Patients are evaluated 3 weeks after the last course of therapy Patients with progressive disease go off study
Radioimmunotherapy Beginning no more than 9 weeks after the reevaluation or 12 weeks after the last dose of R-CHOP patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies Patients then receive rituximab IV followed by yttrium 90-Yttrium ibritumomab tiuxetan IV over 10 minutes on day 8
Radiotherapy Patients with residual disease by CT scan or positron emission tomography PET scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually for 5 years
I To evaluate the complete response rate CR and functional CR rate in patients with previously untreated stage I with at least 1 risk factor or stage II CD20 diffuse large cell lymphoma who receive therapy with R-CHOP followed by 90-Yttrium -Zevalin
SECONDARY OBJECTIVES
I To evaluate the time to treatment failure duration of response and overall survival in these patients who receive therapy with R-CHOP followed by 90-Yttrium -Zevalin
II To evaluate the toxicity of this therapy III To evaluate the toxicity of adding involved field radiation therapy 12 weeks after Zevalin for patients with CTPET residual masses
TERTIARY OBJECTIVES
I To evaluate PET scans pre -and post - R-CHOPZevalin therapy
OUTLINE
R-CHOP rituximab prednisone cyclophosphamide doxorubicinvincristine Patients receive oral prednisone once daily on days 1-5 Patients also receive rituximab IV over several hours followed by cyclophosphamide IV doxorubicin IV and vincristine IV over 30-60 minutes on day 1 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR after 2 courses receive 2 additional courses Patients achieving a partial response uncertain CR or stable disease receive 4 additional courses Patients are evaluated 3 weeks after the last course of therapy Patients with progressive disease go off study
Radioimmunotherapy Beginning no more than 9 weeks after the reevaluation or 12 weeks after the last dose of R-CHOP patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies Patients then receive rituximab IV followed by yttrium 90-Yttrium ibritumomab tiuxetan IV over 10 minutes on day 8
Radiotherapy Patients with residual disease by CT scan or positron emission tomography PET scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually for 5 years
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 |
|---|---|---|---|
| E3402 | OTHER | None | None |
| U10CA021115 | NIH | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |