Clinical trial NCT00070018
Conditions: Lymphoma
Keywords: stage I mantle cell lymphoma stage I adult diffuse large cell lymphoma stage I adult Burkitt lymphoma anaplastic large cell lymphoma contiguous stage II adult diffuse large cell lymphoma contiguous stage II adult Burkitt lymphoma contiguous stage II mantle cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II mantle cell lymphoma
Sponsor: SWOG Cancer Research Network
Start date: 2004-02-01; Completion date: 2015-01-08
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Arms: arm 1: Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m\^2 on day 1, doxorubicin 50 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m\^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
Interventions: intervention 1: rituximab intervention 2: Cyclophosphamide intervention 3: doxorubicin hydrochloride intervention 4: prednisone intervention 5: vincristine sulfate intervention 6: radiation therapy intervention 7: Yttrium-90 ibritumomab tiuxetan intervention 8: Indium-111 ibritumomab tiuxetan
Intervention descriptions: intervention 1: 250 mg/m\^2, as part of Zevalin regimen intervention 2: 750 mg/m\^2 intervention 3: 50 mg/m\^2 intervention 4: 100 mg intervention 5: 1.4 mg/m\^2 intervention 6: 4000-5000 cGy total intervention 7: 0.4 mCi/kg intervention 8: 5 mCi

Protocol documents: