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.
- 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
- Determine the PFS of mid-treatment PET-negative patients treated with these regimens.
- 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
- 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.
Maximum age: 70 Years.
Gender(s): Both.
Veterans Affairs Medical Center - Palo Alto, Palo Alto, California 94304, United States
Front Range Cancer Specialists, Fort Collins, Colorado 80528, United States
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida 32207, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida 32224, United States
Rush-Copley Cancer Care Center, Aurora, Illinois 60504, United States
St. Joseph Medical Center, Bloomington, Illinois 61701, United States
Graham Hospital, Canton, Illinois 61520, United States
Memorial Hospital, Carthage, Illinois 62321, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611-3013, United States
Eureka Community Hospital, Eureka, Illinois 61530, United States
Evanston Northwestern Healthcare - Evanston Hospital, Evanston, Illinois 60201-1781, United States
Galesburg Clinic, PC, Galesburg, Illinois 61401, United States
Galesburg Cottage Hospital, Galesburg, Illinois 61401, United States
Mason District Hospital, Havana, Illinois 62644, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois 60521, United States
Hopedale Medical Complex, Hopedale, Illinois 61747, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois 60435, United States
McDonough District Hospital, Macomb, Illinois 61455, United States
Moline, Illinois 61265, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois 61265, United States
BroMenn Regional Medical Center, Normal, Illinois 61761, United States
Community Cancer Center, Normal, Illinois 61761, United States
Community Hospital of Ottawa, Ottawa, Illinois 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois 61350, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois 61554, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois 61615, United States
Methodist Medical Center of Illinois, Peoria, Illinois 61636, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois 61615, United States
OSF St. Francis Medical Center, Peoria, Illinois 61637, United States
Proctor Hospital, Peoria, Illinois 61614, United States
Illinois Valley Community Hospital, Peru, Illinois 61354, United States
Perry Memorial Hospital, Princeton, Illinois 61356, United States
St. Margaret's Hospital, Spring Valley, Illinois 61362, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, United States
McFarland Clinic, PC, Ames, Iowa 50010, United States
Bettendorf, Iowa 52722, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa 50316, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa 50314, United States
Mercy Capitol Hospital, Des Moines, Iowa 50307, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa 51104, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa 51101, United States
St. Luke's Regional Medical Center, Sioux City, Iowa 51104, United States
Greater Baltimore Medical Center Cancer Center, Baltimore, Maryland 21204, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan 48106-0995, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan 48123-2500, United States
Genesys Hurley Cancer Institute, Flint, Michigan 48503, United States
Hurley Medical Center, Flint, Michigan 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States
Foote Memorial Hospital, Jackson, Michigan 49201, United States
Borgess Medical Center, Kalamazoo, Michigan 49001, United States
Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States
West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, United States
Sparrow Regional Cancer Center, Lansing, Michigan 48912-1811, United States
St. Mary Mercy Hospital, Livonia, Michigan 48154, United States
St. Joseph Mercy Oakland, Pontiac, Michigan 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan 48601, United States
St. John Macomb Hospital, Warren, Michigan 48093, United States
CCOP - Duluth, Duluth, Minnesota 55805, United States
Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota 55805-1983, United States
Miller - Dwan Medical Center, Duluth, Minnesota 55805, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States
SUNY Downstate Medical Center, Brooklyn, New York 11203, United States
NYU Cancer Institute at New York University Medical Center, New York, New York 10016, United States
Aultman Cancer Center at Aultman Hospital, Canton, Ohio 44710-1799, United States
Christ Hospital Cancer Center, Cincinnati, Ohio 45219, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio 44109, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania 19010, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania 17822-0001, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States
Lewistown Hospital, Lewistown, Pennsylvania 17044, United States
Cancer Center of Paoli Memorial Hospital, Paoli, Pennsylvania 19301-1792, United States
Geisinger Medical Group - Scenery Park, State College, Pennsylvania 16801, United States
Mount Nittany Medical Center, State College, Pennsylvania 16803, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania 18711, United States
CCOP - Main Line Health, Wynnewood, Pennsylvania 19096, United States
Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania 19096, United States
Avera Cancer Institute, Sioux Falls, South Dakota 57105, United States
Medical X-Ray Center, PC, Sioux Falls, South Dakota 57105, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota 57117-5039, United States
Center for Cancer Treatment & Prevention at Sacred Heart Hospital, Eau Claire, Wisconsin 54701, United States
Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire, Wisconsin 54701, United States
Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin 54601, United States
Dean Medical Center - Madison, Madison, Wisconsin 53717, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States
Saint Joseph's Hospital, Marshfield, Wisconsin 54449, United States
Froedtert Hospital and Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin 53226, United States
Marshfield Clinic - Lakeland Center, Minocqua, Wisconsin 54548, United States
Ministry Medical Group at Saint Mary's Hospital, Rhinelander, Wisconsin 54501, United States
Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin 54868, United States
Saint Michael's Hospital Cancer Center, Stevens Point, Wisconsin 54481, United States
Marshfield Clinic - Wausau Center, Wausau, Wisconsin 54401, United States
Marshfield Clinic - Weston Center, Weston, Wisconsin 54476, United States
Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin 54494, United States