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Brief Title: Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Official Title: Response-Adapted Therapy for Aggressive Non-Hodgkin's Lymphomas Based on Early [18F] FDG-PET Scanning
Study ID: NCT00274924
Brief Summary: RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin's lymphoma.
Detailed Description: OBJECTIVES: Primary * Determine the 2-year progression-free survival (PFS) rate after treatment with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in patients with bulky stage II or stage III or IV diffuse large B-cell non-Hodgkin's lymphoma who remain positron emission tomography (PET)-positive after 3 courses of rituximab, cyclophosphamide, vincristine, doxorubicin hydrochloride, and prednisone. Secondary * Determine the proportion of mid-treatment PET-positive patients who become PET-negative after 4 courses of R-ICE. * Determine the PFS of mid-treatment PET-negative patients treated with these regimens. * Determine the overall survival of patients treated with these regimens. * Determine the toxicity of these regimens in these patients. OUTLINE: * Rituximab and Combination Chemotherapy (R-CHOP: R= Rituximab, C= Cyclophosphamide, H= Doxorubicin Hydrochloride (Hydroxydaunomycin), O= Vincristine Sulfate (Oncovin), P= Prednisone): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo fludeoxyglucose F18 positron emission tomography (PET) scanning and conventional restaging during course 3. Based on the PET results, patients are assigned to 1 of 2 treatment groups. * Group I (PET negative): Patients receive 2 more courses of R-CHOP as above in the absence of disease progression or unacceptable toxicity. * Group II (PET positive): Patients receive Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 10 years from the date of study entry. ACCRUAL: A total of 100 patients were accrued for this study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Veterans Affairs Medical Center - Palo Alto, Palo Alto, California, United States
Front Range Cancer Specialists, Fort Collins, Colorado, United States
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
St. Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Eureka Community Hospital, Eureka, Illinois, United States
Evanston Northwestern Healthcare - Evanston Hospital, Evanston, Illinois, United States
Galesburg Clinic, PC, Galesburg, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, United States
Hopedale Medical Complex, Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States
McDonough District Hospital, Macomb, Illinois, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois, United States
, Moline, Illinois, United States
BroMenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Community Hospital of Ottawa, Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF St. Francis Medical Center, Peoria, Illinois, United States
Illinois Valley Community Hospital, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
St. Margaret's Hospital, Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
McFarland Clinic, PC, Ames, Iowa, United States
, Bettendorf, Iowa, United States
Mercy Capitol Hospital, Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Greater Baltimore Medical Center Cancer Center, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Foote Memorial Hospital, Jackson, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
St. Mary Mercy Hospital, Livonia, Michigan, United States
St. Joseph Mercy Oakland, Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota, United States
CCOP - Duluth, Duluth, Minnesota, United States
Miller - Dwan Medical Center, Duluth, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
SUNY Downstate Medical Center, Brooklyn, New York, United States
NYU Cancer Institute at New York University Medical Center, New York, New York, United States
Aultman Cancer Center at Aultman Hospital, Canton, Ohio, United States
Christ Hospital Cancer Center, Cincinnati, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Lewistown Hospital, Lewistown, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital, Paoli, Pennsylvania, United States
Geisinger Medical Group - Scenery Park, State College, Pennsylvania, United States
Mount Nittany Medical Center, State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
CCOP - Main Line Health, Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Medical X-Ray Center, PC, Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States
Center for Cancer Treatment & Prevention at Sacred Heart Hospital, Eau Claire, Wisconsin, United States
Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin, United States
Dean Medical Center - Madison, Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Saint Joseph's Hospital, Marshfield, Wisconsin, United States
Froedtert Hospital and Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Marshfield Clinic - Lakeland Center, Minocqua, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital, Rhinelander, Wisconsin, United States
Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin, United States
Saint Michael's Hospital Cancer Center, Stevens Point, Wisconsin, United States
Marshfield Clinic - Wausau Center, Wausau, Wisconsin, United States
Marshfield Clinic - Weston Center, Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, United States
Name: Lode J. Swinnen, MD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: STUDY_CHAIR