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A Phase II Pilot Trial of CHOP Followed by Iodine-131-Labeled Monoclonal Anti-B1 Antibody for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas (NCT00003784)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by monoclonal antibody therapy in treating patients who have newly diagnosed follicular non-Hodgkin's lymphoma.
  • Drug: CHOP regimen
    • Drug: cyclophosphamide
      • Drug: doxorubicin hydrochloride
        • Drug: prednisone
          • Drug: vincristine sulfate
            • Radiation: tositumomab and iodine I 131 tositumomab
              Ages eligible for Study
              18 Years and older
              Genders eligible for Study
              All
              Accepts Healthy Volunteers
              No
              OBJECTIVES: I. Determine the 2 year failure free survival rate of patients with newly diagnosed follicular lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) followed by iodine I 131 monoclonal antibody anti-B1. II. Determine the complete and partial response rates of these patients after this therapy. III. Evaluate the toxicity of this regimen in these patients. IV. Determine the rate of disappearance of cells with clonal t(14;18)/bcl2 rearrangements from the peripheral blood and bone marrow after this therapy in these patients.

              OUTLINE: Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment is repeated every 21 days for up to 6 courses. Within 4-8 weeks after the last course of chemotherapy, patients who achieve at least a partial response and have less than 25% bone marrow involvement begin immunotherapy. Patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV over 1 hour, then iodine I 131 MOAB anti-B1 IV over 20 minutes on day 1. This regimen is repeated on day 8. Patients are followed every 6 months for 2 years, then annually thereafter.

              PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.

              87 locations

              United States (87)
              • MBCCOP - University of South Alabama
                Mobile, Alabama, United States, 36688
              • CCOP - Greater Phoenix
                Phoenix, Arizona, United States, 85006-2726
              • Veterans Affairs Medical Center - Phoenix (Hayden)
                Phoenix, Arizona, United States, 85012
              • Veterans Affairs Medical Center - Tucson
                Tucson, Arizona, United States, 85723
              • Arizona Cancer Center
                Tucson, Arizona, United States, 85724
              • University of Arkansas for Medical Sciences
                Little Rock, Arkansas, United States, 72205
              • Veterans Affairs Medical Center - Little Rock (McClellan)
                Little Rock, Arkansas, United States, 72205
              • Beckman Research Institute, City of Hope
                Duarte, California, United States, 91010
              • Veterans Affairs Medical Center - Long Beach
                Long Beach, California, United States, 90822
              • USC/Norris Comprehensive Cancer Center
                Los Angeles, California, United States, 90033-0800
              • Jonsson Comprehensive Cancer Center, UCLA
                Los Angeles, California, United States, 90095-1781
              • Veterans Affairs Outpatient Clinic - Martinez
                Martinez, California, United States, 94553
              • CCOP - Bay Area Tumor Institute
                Oakland, California, United States, 94609-3305
              • Chao Family Comprehensive Cancer Center
                Orange, California, United States, 92868
              • University of California Davis Medical Center
                Sacramento, California, United States, 95817
              • UCSF Cancer Center and Cancer Research Institute
                San Francisco, California, United States, 94115-0128
              • CCOP - Santa Rosa Memorial Hospital
                Santa Rosa, California, United States, 95403
              • David Grant Medical Center
                Travis Air Force Base, California, United States, 94535
              • Veterans Affairs Medical Center - Denver
                Denver, Colorado, United States, 80220
              • University of Colorado Cancer Center
                Denver, Colorado, United States, 80262
              • CCOP - Atlanta Regional
                Atlanta, Georgia, United States, 30342-1701
              • Dwight David Eisenhower Army Medical Center
                Fort Gordon, Georgia, United States, 30905-5650
              • Cancer Research Center of Hawaii
                Honolulu, Hawaii, United States, 96813
              • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
                Hines, Illinois, United States, 60141
              • Loyola University Medical Center
                Maywood, Illinois, United States, 60153
              • CCOP - Central Illinois
                Springfield, Illinois, United States, 62526
              • University of Kansas Medical Center
                Kansas City, Kansas, United States, 66160-7357
              • CCOP - Wichita
                Wichita, Kansas, United States, 67214-3882
              • Veterans Affairs Medical Center - Wichita
                Wichita, Kansas, United States, 67218
              • Veterans Affairs Medical Center - Lexington
                Lexington, Kentucky, United States, 40511-1093
              • Albert B. Chandler Medical Center, University of Kentucky
                Lexington, Kentucky, United States, 40536-0084
              • MBCCOP - LSU Medical Center
                New Orleans, Louisiana, United States, 70112
              • Tulane University School of Medicine
                New Orleans, Louisiana, United States, 70112
              • Veterans Affairs Medical Center - New Orleans
                New Orleans, Louisiana, United States, 70112
              • Louisiana State University Hospital - Shreveport
                Shreveport, Louisiana, United States, 71130-3932
              • Veterans Affairs Medical Center - Shreveport
                Shreveport, Louisiana, United States, 71130
              • Boston Medical Center
                Boston, Massachusetts, United States, 02118
              • Veterans Affairs Medical Center - Boston (Jamaica Plain)
                Jamaica Plain, Massachusetts, United States, 02130
              • Veterans Affairs Medical Center - Ann Arbor
                Ann Arbor, Michigan, United States, 48105
              • University of Michigan Comprehensive Cancer Center
                Ann Arbor, Michigan, United States, 48109-0752
              • Veterans Affairs Medical Center - Detroit
                Detroit, Michigan, United States, 48201-1932
              • Barbara Ann Karmanos Cancer Institute
                Detroit, Michigan, United States, 48201
              • Henry Ford Hospital
                Detroit, Michigan, United States, 48202
              • CCOP - Grand Rapids Clinical Oncology Program
                Grand Rapids, Michigan, United States, 49503
              • Providence Hospital - Southfield
                Southfield, Michigan, United States, 48075-9975
              • Veterans Affairs Medical Center - Biloxi
                Biloxi, Mississippi, United States, 39531-2410
              • University of Mississippi Medical Center
                Jackson, Mississippi, United States, 39216-4505
              • Veterans Affairs Medical Center - Jackson
                Jackson, Mississippi, United States, 39216
              • Keesler Medical Center - Keesler AFB
                Keesler AFB, Mississippi, United States, 39534-2576
              • Veterans Affairs Medical Center - Kansas City
                Kansas City, Missouri, United States, 64128
              • CCOP - Kansas City
                Kansas City, Missouri, United States, 64131
              • St. Louis University Health Sciences Center
                Saint Louis, Missouri, United States, 63110-0250
              • CCOP - St. Louis-Cape Girardeau
                Saint Louis, Missouri, United States, 63141
              • CCOP - Cancer Research for the Ozarks
                Springfield, Missouri, United States, 65807
              • CCOP - Montana Cancer Consortium
                Billings, Montana, United States, 59101
              • Veterans Affairs Medical Center - Albuquerque
                Albuquerque, New Mexico, United States, 87108-5138
              • University of New Mexico Cancer Research & Treatment Center
                Albuquerque, New Mexico, United States, 87131
              • Veterans Affairs Medical Center - Brooklyn
                Brooklyn, New York, United States, 11209
              • Herbert Irving Comprehensive Cancer Center
                New York, New York, United States, 10032
              • Barrett Cancer Center, The University Hospital
                Cincinnati, Ohio, United States, 45219
              • Veterans Affairs Medical Center - Cincinnati
                Cincinnati, Ohio, United States, 45220-2288
              • Cleveland Clinic Cancer Center
                Cleveland, Ohio, United States, 44195
              • CCOP - Columbus
                Columbus, Ohio, United States, 43206
              • Veterans Affairs Medical Center - Dayton
                Dayton, Ohio, United States, 45428
              • CCOP - Dayton
                Kettering, Ohio, United States, 45429
              • Oklahoma Medical Research Foundation
                Oklahoma City, Oklahoma, United States, 73104
              • Veterans Affairs Medical Center - Oklahoma City
                Oklahoma City, Oklahoma, United States, 73104
              • Oregon Cancer Center at Oregon Health Sciences University
                Portland, Oregon, United States, 97201-3098
              • Veterans Affairs Medical Center - Portland
                Portland, Oregon, United States, 97207
              • CCOP - Columbia River Program
                Portland, Oregon, United States, 97213
              • CCOP - Greenville
                Greenville, South Carolina, United States, 29615
              • CCOP - Upstate Carolina
                Spartanburg, South Carolina, United States, 29303
              • Brooke Army Medical Center
                Fort Sam Houston, Texas, United States, 78234
              • University of Texas Medical Branch
                Galveston, Texas, United States, 77555-1329
              • Texas Tech University Health Science Center
                Lubbock, Texas, United States, 79423
              • University of Texas Health Science Center at San Antonio
                San Antonio, Texas, United States, 78284
              • Veterans Affairs Medical Center - San Antonio (Murphy)
                San Antonio, Texas, United States, 78284
              • Veterans Affairs Medical Center - Temple
                Temple, Texas, United States, 76504
              • CCOP - Scott and White Hospital
                Temple, Texas, United States, 76508
              • Huntsman Cancer Institute
                Salt Lake City, Utah, United States, 84132
              • Veterans Affairs Medical Center - Salt Lake City
                Salt Lake City, Utah, United States, 84148
              • CCOP - Virginia Mason Research Center
                Seattle, Washington, United States, 98101
              • Swedish Cancer Institute
                Seattle, Washington, United States, 98104
              • Veterans Affairs Medical Center - Seattle
                Seattle, Washington, United States, 98108
              • Fred Hutchinson Cancer Research Center
                Seattle, Washington, United States, 98109
              • University of Washington Medical Center
                Seattle, Washington, United States, 98195-6043
              • CCOP - Northwest
                Tacoma, Washington, United States, 98405-0986
              Status:
              completed
              Type:
              Interventional
              Phase:
              Start:
              30 April, 1999
              Updated:
              22 January, 2013
              Participants:
              102
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