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
Status: | Active, not recruiting |
---|---|
Conditions: | Lymphoma, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/5/2019 |
Start Date: | February 2004 |
End Date: | November 2020 |
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
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.
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.
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.
- 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.
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
We found this trial at
48
sites
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Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
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601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-5830
James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
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Group Health Central Hospital Group Health Cooperative is a member-governed, nonprofit health care system that...
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747 Broadway
Seattle, Washington 98122
Seattle, Washington 98122
206-386-6000
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Since 1910, Swedish has...
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1959 NE Pacific St
Seattle, Washington 98195
Seattle, Washington 98195
(206) 598-4100
University Cancer Center at University of Washington Medical Center The Division of Radiation Oncology's work...
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825 N Emporia Ave
Wichita, Kansas 67214
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
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1 Akron General Ave
Akron, Ohio 44307
Akron, Ohio 44307
(330) 344-6000
McDowell Cancer Center at Akron General Medical Center Learning that you or someone you love...
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300 North Ave
Battle Creek, Michigan 49017
Battle Creek, Michigan 49017
(269) 245-8000
Battle Creek Health System Cancer Care Center As a proud member of the Battle Creek...
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Mecosta County Medical Center Spectrum Health is a not-for-profit system of care dedicated to improving...
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Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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2300 N. Edward Street
Decatur, Illinois 62526
Decatur, Illinois 62526
217-876-8121
Decatur Memorial Hospital Cancer Care Institute An American flag bearing only 48 stars waved above...
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Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
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Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
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250 Cherry St SE
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
(616) 685-5225
Lacks Cancer Center at Saint Mary's Health Care Mercy Health Lacks Cancer Center was one...
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CCOP - Grand Rapids The Grand Rapids Clinical Oncology Program (GRCOP) is a community cancer...
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Cancer Center of Kansas-Independence Dr. H.E. Hynes founded Cancer Center of Kansas, P. A. in...
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Cancer Center of Kansas, PA - Kingman Dr. H.E. Hynes founded Cancer Center of Kansas,...
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2160 S. First Ave.
Maywood, Illinois 60153
Maywood, Illinois 60153
888-584-7888
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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Cancer Center of Kansas, PA - Newton Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Cancer Center of Kansas, PA - Parsons Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Cancer Center of Kansas, PA - Pratt Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Cancer Center of Kansas, PA - Salina Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Minor and James Medical, PLLC In 1959 a group of the most respected physicians in...
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701 N 1st St
Springfield, Illinois 62781
Springfield, Illinois 62781
(217) 788-4400
Regional Cancer Center at Memorial Medical Center At Memorial's Regional Cancer Center, we understand the...
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Cotton-O'Neil Cancer Center The state-of-the-art Stormont-Vail Cancer Center is one of the specialty medical centers...
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Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
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Cancer Center of Kansas, PA - Wellington Dr. H.E. Hynes founded Cancer Center of Kansas,...
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8710 W 13th St N # 100
Wichita, Kansas 67208
Wichita, Kansas 67208
(316) 722-5141
Associates in Womens Health, PA - North Review On January 1, 1997, four prominent practices,...
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Wesley Medical Center Welcome to one of the most experienced and comprehensive medical centers in...
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Cancer Center of Kansas, PA - Winfield Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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