S0014 Combination Chemotherapy Plus Rituximab and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma



Status:Active, not recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2000
End Date:January 2017

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Evaluation of CHOP Plus Rituximab Plus Involved Field Radiotherapy for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized Aggressive Histologies of Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer
cells and either kill them or deliver cancer-killing substances to them without harming
normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining
chemotherapy with monoclonal antibody therapy and radiation therapy may kill more cancer
cells.

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

OBJECTIVES: I. Assess two year progression free survival after treatment with
cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus rituximab followed by
radiotherapy in patients with stage I, IE, or non-bulky stage II or IIE high risk localized
intermediate or high grade non-Hodgkin's lymphoma. II. Determine the toxicity of this
treatment in these patients.

OUTLINE: Patients receive rituximab IV on days 1 and 8 of the first course, then on day 1 of
courses 2 and 3. Patients receive cyclophosphamide IV over 1-2 hours, doxorubicin IV, and
vincristine IV on day 10 of the first course, then on day 3 of courses 2 and 3. Patients
receive oral prednisone on days 10-14 of the first course, then on days 3-7 of courses 2 and
3. Treatment repeats every 21 days for 3 courses in the absence of disease progression or
unacceptable toxicity. Chemotherapy is followed by radiotherapy administered 5 days a week
for 4-5 weeks. Patients are followed every 6 months for two years, and then annually
thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

DISEASE CHARACTERISTICS: Histologically confirmed stage I, IE, or non-bulky II or IIE
non-Hodgkin's lymphoma of one 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)
Lymphoma must express CD20 All disease must be encompassable in a single radiation port
(including any resected disease) Must have at least 1 of the following adverse prognostic
features: Non-bulky stage II or non-bulky stage IIE disease Over 60 years of age Zubrod
performance status of 2 Elevated serum LDH 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:
No medical contraindications to CHOP chemotherapy or rituximab No prior malignancy within
past 5 years except adequately treated basal cell or squamous cell skin cancer or
carcinoma in situ of the cervix No AIDS or HIV Not pregnant or nursing Fertile patients
must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibody therapy
Chemotherapy: No prior chemotherapy for lymphoma Endocrine therapy: Not specified
Radiotherapy: No prior radiotherapy for lymphoma Surgery: Not specified
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2010 E 90th St
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4100 John R
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3551 Roger Brooke Dr
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301 University Blvd
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33 Villa Road, Suite 400
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701 Ilalo Street Suite 600
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2500 N State St
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4502 Medical Drive
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Atlanta, Georgia 30342
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
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3901 Rainbow Blvd
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Oklahoma City, Oklahoma 73104
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940 NE 13th St
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Orange, California 92868
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Portland, Oregon 97201
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Portland, Oregon 97225
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
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3437 Caroline Mall
Saint Louis, Missouri 63110
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1730 E Republic Rd
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9040 Jackson Ave
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