Non Hodgkin Lymphoma Clinical Trial
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
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.
Full 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.
Eligibility Criteria
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
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There are 39 Locations for this study
Anchorage Alaska, 99508, United States
Anchorage Alaska, 99508, United States
Burbank California, 91505, United States
Boise Idaho, 83712, United States
Decatur Illinois, 62526, United States
Maywood Illinois, 60153, United States
Naperville Illinois, 60540, United States
Springfield Illinois, 62781, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Independence Kansas, 67301, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Topeka Kansas, 66606, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Battle Creek Michigan, 49017, United States
Big Rapids Michigan, 49307, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Muskegon Michigan, 49442, United States
Southfield Michigan, 48075, United States
Traverse City Michigan, 49684, United States
Wyoming Michigan, 49519, United States
Rochester New York, 14642, United States
Akron Ohio, 44307, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Independence Ohio, 44131, United States
Wooster Ohio, 44691, United States
Greenville South Carolina, 29615, United States
Seattle Washington, 98104, United States
Seattle Washington, 98112, United States
Seattle Washington, 98122, United States
Seattle Washington, 98122, United States
Seattle Washington, 98195, United States
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