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 |
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.
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.
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
We found this trial at
92
sites
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
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Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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533 Bolivar Street, Room 420
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
(504) 568-3435
MBCCOP - LSU Health Sciences Center Established in 1990, the Stanley S. Scott Cancer Center...
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CCOP - Bay Area Tumor Institute he Bay Area Tumor Institute Community Clinical Oncology Program...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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2315 Stockton Blvd.
Sacramento, California 95817
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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CCOP - Cancer Research for the Ozarks Cancer Research for the Ozarks (CRO), also known...
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Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
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