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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: 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

Study ID: NCT00070018

Conditions

Lymphoma

Study Description

Brief 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.

Detailed 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Alaska Regional Hospital Cancer Center, Anchorage, Alaska, United States

Providence Cancer Center, Anchorage, Alaska, United States

Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States

Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise, Idaho, United States

Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States

Edward Hospital Cancer Center, Naperville, Illinois, United States

Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, United States

Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States

Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States

Cancer Center of Kansas-Independence, Independence, Kansas, United States

Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States

Southwest Medical Center, Liberal, Kansas, United States

Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States

Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States

Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States

Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States

Cotton-O'Neil Cancer Center, Topeka, Kansas, United States

Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States

Associates in Womens Health, PA - North Review, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States

CCOP - Wichita, Wichita, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States

Wesley Medical Center, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States

Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, United States

Mecosta County Medical Center, Big Rapids, Michigan, United States

Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States

CCOP - Grand Rapids, Grand Rapids, Michigan, United States

Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States

Hackley Hospital, Muskegon, Michigan, United States

Providence Cancer Institute at Providence Hospital - Southfield Campus, Southfield, Michigan, United States

Munson Medical Center, Traverse City, Michigan, United States

Metro Health Hospital, Wyoming, Michigan, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States

McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States

Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States

Community Oncology Group at Cleveland Clinic Cancer Center, Independence, Ohio, United States

Cleveland Clinic - Wooster, Wooster, Ohio, United States

CCOP - Greenville, Greenville, South Carolina, United States

Minor and James Medical, PLLC, Seattle, Washington, United States

Group Health Central Hospital, Seattle, Washington, United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington, United States

Polyclinic First Hill, Seattle, Washington, United States

University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States

Contact Details

Name: Thomas P. Miller, MD

Affiliation: University of Arizona

Role: STUDY_CHAIR

Name: Oliver W. Press, MD, PhD

Affiliation: Fred Hutchinson Cancer Center

Role: STUDY_CHAIR

Name: Baldassarre D. Stea, MD, PhD

Affiliation: University of Arizona

Role: STUDY_CHAIR

Name: Louis S. Constine, MD

Affiliation: James P. Wilmot Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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