Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107380
Status:
COMPLETED
Last Update Posted:
2016-03-07
First Post:
2005-04-05
Brief Title:
S0433 Iodine I 131 Tositumomab Rituximab and Combination Chemotherapy in Treating Older Patients With Stage II Stage III or Stage IV Non-Hodgkins Lymphoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Iodine-131-Labeled Monoclonal Anti-B1 Antibody I-131 Tositumomab in Combination With Cyclophosphamide Doxorubicin Vincristine Prednisone and Rituximab Therapy for Patients Age 60 With Advanced Stage Diffuse Large B-Cell NHL A Phase II Study
Status:
COMPLETED
Status Verified Date:
2016-02
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 iodine I 131 tositumomab can find cancer cells and carry cancer-killing substances to them without harming normal cells 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 Drugs used in chemotherapy such as cyclophosphamide doxorubicin vincristine and prednisone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving a radiolabeled monoclonal antibody together with rituximab and combination chemotherapy may kill more cancer cells
PURPOSE This phase II trial is studying how well giving iodine I 131 tositumomab together with rituximab and combination chemotherapy works in treating older patients with stage II stage III or stage IV B-cell non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving iodine I 131 tositumomab together with rituximab and combination chemotherapy works in treating older patients with stage II stage III or stage IV B-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the 2-year progression-free survival of older patients with previously untreated bulky stage II or stage III or IV diffuse large B-cell non-Hodgkins lymphoma treated with iodine I 131 tositumomab in combination with rituximab cyclophosphamide doxorubicin vincristine and prednisone
Determine the response rate partial response complete unconfirmed response and complete response in patients treated with this regimen
Determine the 2-year progression-free survival and response rate partial response complete unconfirmed response and complete response in B-cell lymphoma 2 BCL-2 positive patients treated with this regimen
OUTLINE This is a multicenter study
Rituximab and chemotherapy Patients receive R-CHOP comprising rituximab IV over 6 hours cyclophosphamide IV over 15-45 minutes doxorubicin IV over 5-20 minutes and vincristine IV over 5-15 minutes on day 1 and oral prednisone on days 1-5 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients then undergo a restaging evaluation Patients without progressive disease receive CHOP chemotherapy comprising cyclophosphamide doxorubicin vincristine and prednisone as outlined above Treatment with CHOP chemotherapy repeats every 21 days for 2 courses
Radiolabeled monoclonal antibody therapy Approximately 4-8 weeks after completion of chemotherapy patients receive tositumomab IV over 1 hour followed by a dosimetric dose of iodine I 131 tositumomab IV over 20 minutes Patients then undergo gamma scans over a 1-week period in order to determine the correct treatment dose of iodine I 131 tositumomab No more than 2 weeks after administration of the dosimetric dose patients receive tositumomab IV over 1 hour followed by a treatment dose of iodine I 131 tositumomab IV over 20 minutes
After completion of study treatment patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study within 15 months
Determine the 2-year progression-free survival of older patients with previously untreated bulky stage II or stage III or IV diffuse large B-cell non-Hodgkins lymphoma treated with iodine I 131 tositumomab in combination with rituximab cyclophosphamide doxorubicin vincristine and prednisone
Determine the response rate partial response complete unconfirmed response and complete response in patients treated with this regimen
Determine the 2-year progression-free survival and response rate partial response complete unconfirmed response and complete response in B-cell lymphoma 2 BCL-2 positive patients treated with this regimen
OUTLINE This is a multicenter study
Rituximab and chemotherapy Patients receive R-CHOP comprising rituximab IV over 6 hours cyclophosphamide IV over 15-45 minutes doxorubicin IV over 5-20 minutes and vincristine IV over 5-15 minutes on day 1 and oral prednisone on days 1-5 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients then undergo a restaging evaluation Patients without progressive disease receive CHOP chemotherapy comprising cyclophosphamide doxorubicin vincristine and prednisone as outlined above Treatment with CHOP chemotherapy repeats every 21 days for 2 courses
Radiolabeled monoclonal antibody therapy Approximately 4-8 weeks after completion of chemotherapy patients receive tositumomab IV over 1 hour followed by a dosimetric dose of iodine I 131 tositumomab IV over 20 minutes Patients then undergo gamma scans over a 1-week period in order to determine the correct treatment dose of iodine I 131 tositumomab No more than 2 weeks after administration of the dosimetric dose patients receive tositumomab IV over 1 hour followed by a treatment dose of iodine I 131 tositumomab IV over 20 minutes
After completion of study treatment patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study within 15 months
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 |
|---|---|---|---|
| S0433 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |