Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
Eligibility Criteria
INCLUSION CRITERIA: Diffuse large B-cell non-Hodgkin's lymphoma Bulky stage II (bulk defined as any lesion ≥ 10 cm) or stage III or IV disease The following lymphoma types are excluded: Primary central nervous system lymphoma Transformed low-grade lymphoma (prior history of low-grade lymphoma or clear presence of low-grade lymphoma on histologic sections) Primary mediastinal B-cell lymphoma or testicular lymphoma (consolidative radiotherapy is usually indicated) Immunodeficiency-related lymphoma (i.e., after organ or bone marrow transplant) Measurable disease Patient must have at least one objective measurable disease site (i.e., measurable in at least 2 perpendicular parameters) Measurable disease in the liver is required if the liver is the only site of lymphoma involvement Abnormal positron emission tomography scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging Eastern Cooperative Oncology Group (ECOG) performance status 0-3 For patients > 50 years of age, a normal ejection fraction by ECHO or Multigated Acquisition Scan (MUGA) is required within 6 weeks prior to registration Absolute neutrophil count ≥ 1,500/mm^3 Platelet count > 100,000/mm^3 Creatinine < 2.0 mg/dL Bilirubin < 2 mg/dL (may be up to 3.0 mg/dL if due to liver involvement by lymphoma) EXCLUSION CRITERIA: Prior chemotherapy or radiation therapy for lymphoma Prior anthracyclines or platinum compounds used as systemic chemotherapy Prior radiation therapy to the mediastinum or to ≥ 25% of the bone marrow Concurrent pentostatin or trastuzumab (Herceptin®) Pregnant or nursing Prior malignancy within the past 5 years unless it was in situ OR was treated with curative intent AND the patient has remained relapse-free HIV positive
Sites / Locations
- Veterans Affairs Medical Center - Palo Alto
- Front Range Cancer Specialists
- Baptist Cancer Institute - Jacksonville
- Mayo Clinic - Jacksonville
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Eureka Community Hospital
- Evanston Northwestern Healthcare - Evanston Hospital
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- Mason District Hospital
- Hinsdale Hematology Oncology Associates
- Hopedale Medical Complex
- Joliet Oncology-Hematology Associates, Limited - West
- McDonough District Hospital
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Saint Anthony Memorial Health Centers
- McFarland Clinic, PC
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Greater Baltimore Medical Center Cancer Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- St. John Macomb Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- Mayo Clinic Cancer Center
- Newark Beth Israel Medical Center
- SUNY Downstate Medical Center
- NYU Cancer Institute at New York University Medical Center
- Aultman Cancer Center at Aultman Hospital
- Christ Hospital Cancer Center
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- Bryn Mawr Hospital
- Geisinger Cancer Institute at Geisinger Health
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Lewistown Hospital
- Cancer Center of Paoli Memorial Hospital
- Geisinger Medical Group - Scenery Park
- Mount Nittany Medical Center
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- CCOP - Main Line Health
- Lankenau Cancer Center at Lankenau Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Center for Cancer Treatment & Prevention at Sacred Heart Hospital
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Gundersen Lutheran Center for Cancer and Blood
- Dean Medical Center - Madison
- Marshfield Clinic - Marshfield Center
- Saint Joseph's Hospital
- Froedtert Hospital and Medical College of Wisconsin
- Medical College of Wisconsin Cancer Center
- Marshfield Clinic - Lakeland Center
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Indianhead Center
- Saint Michael's Hospital Cancer Center
- Marshfield Clinic - Wausau Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group I (PET negative)
Group II (PET positive)
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 2 courses in the absence of disease progression or unacceptable toxicity.
Patients receive R-ICE comprising rituximab IV on day 1, ifosfamide IV continuously over 24 hours and carboplatin IV over 30 minutes on day 2, and etoposide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously once daily starting on day 4 and continuing until blood counts recover. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.