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: Phase II trial to study the effectiveness of combining combination chemotherapy with radiation therapy and monoclonal antibody therapy in treating patients who have stage I or stage II non-Hodgkin's lymphoma.

Condition	Treatment or Intervention	Phase
adult Burkitt's lymphoma adult diffuse large cell lymphoma adult non-Hodgkin's lymphoma anaplastic large cell lymphoma Mantle Cell Lymphoma	Drug: cyclophosphamide  Drug: doxorubicin  Drug: prednisone  Drug: rituximab  Drug: vincristine  Drug: yttrium Y 90 ibritumomab tiuxetan  Procedure: antibody therapy  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: isotope therapy  Procedure: monoclonal antibody therapy  Procedure: radiation therapy  Procedure: radioimmunotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the 2-year progression-free survival of patients with aggressive 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Alaska
      Providence Alaska Medical Center, Anchorage,  Alaska,  99519-6604,  United States; Recruiting
Arizona
      Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson,  Arizona,  85724,  United States; Recruiting
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
      Tripler Army Medical Center, Honolulu,  Hawaii,  96859-5000,  United States; Recruiting
Illinois
      Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood,  Illinois,  60153-5500,  United States; Recruiting
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
      Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City,  Kansas,  66160-7353,  United States; Recruiting
Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States; Recruiting
Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      Josephine Ford Cancer Center at Henry Ford Health System, Detroit,  Michigan,  48202,  United States; Recruiting
      Providence Cancer Institute at Providence Hospital - Southfield, Southfield,  Michigan,  48075,  United States; Recruiting
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States; Recruiting
Missouri
      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States; Recruiting
New York
      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195-9001,  United States; Recruiting
South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States; Recruiting
Texas
      Brooke Army Medical Center, Fort Sam Houston,  Texas,  78234-6200,  United States; Recruiting
Washington
      Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle,  Washington,  98104,  United States; Recruiting

Study chairs or principal investigators

Thomas P. Miller, MD,  Arizona Cancer Center   
Oliver W. Press, MD, PhD,  Fred Hutchinson Cancer Research Center   
Baldassarre Dino Stea, MD, PhD,  Arizona Cancer Center   
Louis S. Constine, MD,  James P. Wilmot Cancer Center   

Study ID Numbers:  CDR0000329864; SWOG-S0313; NCT00070018
Record last reviewed:  March 2005
Last Updated:  March 15, 2005
Record first received:  October 3, 2003
ClinicalTrials.gov Identifier:  NCT00070018
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08