NCT00070018

S0313 Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Radiation Therapy Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

Evaluation of CHOP Plus Involved Field Radiotherapy Followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized, Aggressive Histologies of Non-Hodgkin Lymphoma, Phase II

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. 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. Combining chemotherapy with radiation therapy and monoclonal antibody therapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy and monoclonal antibody therapy works in treating patients with stage I or stage II non-Hodgkin's lymphoma.

Detailed description

OBJECTIVES: * Determine the 2-year progression-free survival of patients with aggressive high-risk stage I or IE or non-bulky stage II or IIE CD20-positive non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone and radiotherapy followed by rituximab and yttrium Y 90 ibritumomab tiuxetan. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. * Chemotherapy: Patients receive CHOP chemotherapy comprising cyclophosphamide IV over 1-2 hours, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. * Radiotherapy: Beginning 3 weeks after the completion of CHOP chemotherapy, patients undergo radiotherapy once daily 5 days a week for 4-5 weeks. * Monoclonal antibody therapy: Beginning 3-6 weeks after the completion of radiotherapy, patients receive rituximab IV followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients then undergo whole body imaging. If ibritumomab tiuxetan biodistribution is acceptable, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7, 8, OR 9. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 15 months.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	250 mg/m\^2, as part of Zevalin regimen
DRUG	Cyclophosphamide	750 mg/m\^2
DRUG	doxorubicin hydrochloride	50 mg/m\^2
DRUG	prednisone	100 mg
DRUG	vincristine sulfate	1.4 mg/m\^2
RADIATION	radiation therapy	4000-5000 cGy total
BIOLOGICAL	Yttrium-90 ibritumomab tiuxetan	0.4 mCi/kg
BIOLOGICAL	Indium-111 ibritumomab tiuxetan	5 mCi

Timeline

• Start date: 2004-02-01
• Primary completion: 2010-11-01
• Completion: 2015-01-08
• First posted: 2003-10-07
• Last updated: 2022-01-11
• Results posted: 2012-04-03

Locations

48 sites across 1 country: United States