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

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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.

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.

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
1959 NE Pacific St
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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2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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33 Villa Road, Suite 400
Greenville, South Carolina 29615
(864) 404-2045
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
(585) 275-5830
James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
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201 16th Avenue East
Seattle, Washington 98112
(206) 326-3000
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
206-386-6000
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Since 1910, Swedish has...
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825 N Emporia Ave
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
(330) 344-6000
McDowell Cancer Center at Akron General Medical Center Learning that you or someone you love...
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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300 North Ave
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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605 Oak St
Big Rapids, Michigan 49307
(231) 796-8691
Mecosta County Medical Center Spectrum Health is a not-for-profit system of care dedicated to improving...
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Cincinnati, Ohio 45267
513-584-7698
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2300 N. Edward Street
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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2020 Central Ave
Dodge City, Kansas 67801
(620) 227-2488
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
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700 West Central
El Dorado, Kansas 67042
(316) 889-0099
Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
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Grand Rapids, Michigan 49503
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250 Cherry St SE
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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100 Michigan Street, NE, MC012
Grand Rapids, Michigan 49503
(616) 391-1230
CCOP - Grand Rapids The Grand Rapids Clinical Oncology Program (GRCOP) is a community cancer...
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800 W. Laurel
Independence, Kansas 67301
620-331-4099
Cancer Center of Kansas-Independence Dr. H.E. Hynes founded Cancer Center of Kansas, P. A. in...
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750 Avenue D West
Kingman, Kansas 67068
(620) 532-3147
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Liberal, Kansas 67901
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2160 S. First Ave.
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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Muskegon, Michigan 49442
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Naperville, Illinois 60540
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720 Medical Center Drive
Newton, Kansas 67114
(316) 282-0888
Cancer Center of Kansas, PA - Newton Dr. H.E. Hynes founded Cancer Center of Kansas,...
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1902 S. US Hwy 59
Parsons, Kansas 67357
(620) 421-2855
Cancer Center of Kansas, PA - Parsons Dr. H.E. Hynes founded Cancer Center of Kansas,...
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124 Commodore, Ste. A
Pratt, Kansas 67124
(620) 672-2478
Cancer Center of Kansas, PA - Pratt Dr. H.E. Hynes founded Cancer Center of Kansas,...
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600 S Santa Fe Ave
Salina, Kansas 67401
(785) 823-1521
Cancer Center of Kansas, PA - Salina Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Seattle, Washington 98122
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1229 Madison St
Seattle, Washington 98104
(206) 292-1110
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
(217) 788-4400
Regional Cancer Center at Memorial Medical Center At Memorial's Regional Cancer Center, we understand the...
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1414 SW 8th Ave
Topeka, Kansas 66606
(785) 354-5300
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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105 Sixth St
Traverse City, Michigan 49684
(231) 935-5000
Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
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1323 N. A
Wellington, Kansas 67152
(620) 326-7453 Ext. 224
Cancer Center of Kansas, PA - Wellington Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Wichita, Kansas 67214
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8710 W 13th St N # 100
Wichita, Kansas 67208
(316) 722-5141
Associates in Womens Health, PA - North Review On January 1, 1997, four prominent practices,...
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550 N Hillside St
Wichita, Kansas 67214
(316) 962-2000
Wesley Medical Center Welcome to one of the most experienced and comprehensive medical centers in...
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1305 E 5th Ave
Winfield, Kansas 67156
(620) 221-6125
Cancer Center of Kansas, PA - Winfield Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Wooster, Ohio 44691
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5900 Byron Center Ave SW
Wyoming, Michigan 49519
(616) 252-7200
Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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