Non Hodgkin Lymphoma Clinical Trial

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

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

46

Study ID:

NCT00070018

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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There are 39 Locations for this study

See Locations Near You

Alaska Regional Hospital Cancer Center
Anchorage Alaska, 99508, United States
Providence Cancer Center
Anchorage Alaska, 99508, United States
Providence Saint Joseph Medical Center - Burbank
Burbank California, 91505, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise Idaho, 83712, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois, 60153, United States
Edward Hospital Cancer Center
Naperville Illinois, 60540, United States
Regional Cancer Center at Memorial Medical Center
Springfield Illinois, 62781, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas-Independence
Independence Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Cotton-O'Neil Cancer Center
Topeka Kansas, 66606, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Wesley Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Battle Creek Health System Cancer Care Center
Battle Creek Michigan, 49017, United States
Mecosta County Medical Center
Big Rapids Michigan, 49307, United States
Butterworth Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States
CCOP - Grand Rapids
Grand Rapids Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids Michigan, 49503, United States
Hackley Hospital
Muskegon Michigan, 49442, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield Michigan, 48075, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
Metro Health Hospital
Wyoming Michigan, 49519, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
McDowell Cancer Center at Akron General Medical Center
Akron Ohio, 44307, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45267, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Community Oncology Group at Cleveland Clinic Cancer Center
Independence Ohio, 44131, United States
Cleveland Clinic - Wooster
Wooster Ohio, 44691, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
Minor and James Medical, PLLC
Seattle Washington, 98104, United States
Group Health Central Hospital
Seattle Washington, 98112, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle Washington, 98122, United States
Polyclinic First Hill
Seattle Washington, 98122, United States
University Cancer Center at University of Washington Medical Center
Seattle Washington, 98195, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

46

Study ID:

NCT00070018

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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