This trial is active, not recruiting.

Condition lymphoma
Treatments rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate, radiation therapy, yttrium-90 ibritumomab tiuxetan, indium-111 ibritumomab tiuxetan
Phase phase 2
Target CD20
Sponsor Southwest Oncology Group
Collaborator National Cancer Institute (NCI)
Start date February 2004
End date November 2010
Trial size 46 participants
Trial identifier NCT00070018, CDR0000329864, S0313, U10CA032102


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
250 mg/m^2, as part of Zevalin regimen
750 mg/m^2
doxorubicin hydrochloride
50 mg/m^2
100 mg
vincristine sulfate
1.4 mg/m^2
radiation therapy
4000-5000 cGy total
yttrium-90 ibritumomab tiuxetan
0.4 mCi/kg
indium-111 ibritumomab tiuxetan
5 mCi

Primary Outcomes

Progression-free Survival
time frame: at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes: - Diffuse large B-cell - Mantle cell - High-grade B-cell, Burkitt's, or Burkitt-like - Anaplastic large cell (B-cell phenotype only) - Stage I, IE, or non-bulky* stage II or IIE disease by Ann Arbor classification - Patients who have bulky stage II or IIE disease are ineligible even if, after resection, the measurements are less than 10.0 cm NOTE: *Non-bulky disease defined as any tumor measuring less than 10.0 cm or occupying less than 1/3 of the chest diameter - CD20-expressing disease by flow cytometry or immunoperoxidase staining - Aggressive lymphomas must have at least 1 of the following adverse prognostic factors: - Non-bulky stage II or IIE disease - At least 60 years of age - Zubrod performance status of 2 - Lactic dehydrogenase greater than upper limit of normal - All disease must be encompassable in a single radiation port (including any site of resected disease) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age - Over 18 Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No medical contraindication to study chemotherapy, rituximab, or ibritumomab tiuxetan - No known AIDS syndrome or HIV-associated complex PRIOR CONCURRENT THERAPY: Biologic therapy - No prior monoclonal antibody therapy Chemotherapy - No prior chemotherapy for lymphoma Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy for lymphoma - No concurrent intensity-modulated radiotherapy - Planned involved-field radiotherapy must not encompass more than 25% of active bone marrow space Surgery - See Disease Characteristics Other - Concurrent participation in SWOG-8947 or SWOG-8819 allowed

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Southwest Oncology Group.