Rituximab and Galiximab in Treating Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma
Eligibility Criteria
Documentation of Disease 1.1 Previously untreated, histologically confirmed follicular lymphoma, WHO classification, grade 1, 2, or 3a (> 15 centroblasts per high power field with centrocytes present) which is stage III, IV, or bulky (i.e., single mass ≥ 7 cm in any unidimensional measurement) stage II. 1.1.1 Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies. Fine needle aspirates are not acceptable. 1.1.2 Failure to submit pathology specimens within 60 days of patient registration will result in the patient being declared ineligible. 1.2 Institutional flow cytometry or immunohistochemistry must confirm CD20 antigen expression. 1.3 Patients classified as high risk according to the Follicular Lymphoma International Prognostic Index (FLIPI) should be considered for CALGB 50102/SWOG S0016 (A Phase III Trial of CHOP vs CHOP + Rituximab vs CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody [Tositumomab] For Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas). Prior Treatment 2.1 No prior therapy for non-Hodgkin lymphoma including chemotherapy, radiation or immunotherapy (e.g., monoclonal antibody-based therapy) 2.2 No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease Age - Patients must be ≥ 18 years of age ECOG Performance Status - Patients must have ECOG Performance Status 0-2. Measurable Disease - Measurable disease must be present either on physical examination or imaging studies. 5.1 Non-measurable disease alone is not acceptable. 5.2 Any tumor mass > 1 cm is acceptable. 5.3 Lesions that are considered non-measurable include the following: Bone lesions (lesions if present should be noted) Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Bone marrow (involvement by non-Hodgkin lymphoma should be noted). CNS Involvement - Patients must have no known CNS involvement by lymphoma. HIV Infection - Patients must have no known HIV infection. 7.1 Patients with a history of intravenous drug abuse or any behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. 7.2 Patients who test positive or who are known to be infected are not eligible due to an increased risk of infection with this regimen. An HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk. Human Anti-Chimeric Antibody - Patients must have no known baseline human anti-chimeric antibody (HACA) positivity. Pregnancy and Nursing Status - Patients must be non-pregnant and non-nursing. 9.1 Due to the unknown teratogenic potential of galiximab, pregnant or nursing patients may not be enrolled. 9.2 Women and men of reproductive potential should agree to use an effective means of birth control throughout their participation in this study. 9.3 Appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom). Second Malignancy - Patients with a "currently active" second malignancy, other than non-melanoma skin cancers are not eligible. 10.1 This includes Waldenstrom's Macroglobulinemia, since such patients have experienced transient increases in IgM following initiation of rituximab, with the potential for hyperviscosity syndrome requiring plasmapheresis. 10.2 Patients are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy, and are considered by their physician to be at less than 30% risk of relapse. Required Initial Laboratory Values: ANC ≥ 1000/µL Platelet Count ≥ 50,000/µL Creatinine ≤ 2 x ULN Unless attributable to lymphoma Total Bilirubin ≤ 2 x ULN*† Unless attributable to Gilbert's disease
Sites / Locations
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- Memorial Cancer Institute at Memorial Regional Hospital
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- CCOP - Mount Sinai Medical Center
- Graham Hospital
- Memorial Hospital
- University of Chicago Cancer Research Center
- Eureka Community Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- Kewanee Hospital
- McDonough District Hospital
- 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
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Fort Wayne Medical Oncology and Hematology
- Iowa Blood and Cancer Care
- St. Luke's Hospital
- Mercy Regional Cancer Center at Mercy Medical Center
- Holden Comprehensive Cancer Center at University of Iowa
- CancerCare of Maine at Eastern Maine Medial Center
- UMASS Memorial Cancer Center - University Campus
- Veterans Affairs Medical Center - Minneapolis
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Capital Region Cancer Center
- Siteman Cancer Center at Barnes-Jewish Hospital
- Missouri Baptist Cancer Center
- New Hampshire Oncology-Hematology, PA - Hooksett
- Kingsbury Center for Cancer Care at Cheshire Medical Center
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Elliot Regional Cancer Center
- Frisbie Memorial Hospital
- Roswell Park Cancer Institute
- Charles R. Wood Cancer Center at Glens Falls Hospital
- Long Island Jewish Medical Center
- Memorial Sloan-Kettering Cancer Center
- New York Weill Cornell Cancer Center at Cornell University
- CCOP - Hematology-Oncology Associates of Central New York
- Community General Hospital of Greater Syracuse
- CaroMont Cancer Center at Gaston Memorial Hospital
- Wayne Memorial Hospital, Incorporated
- Wayne Radiation Oncology
- Pardee Memorial Hospital
- Lenoir Memorial Cancer Center
- Wilson Medical Center
- Wake Forest University Comprehensive Cancer Center
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- McLeod Regional Medical Center
- Bon Secours St. Francis Health System
- CCOP - Greenville
- Mountainview Medical
- Fletcher Allen Health Care - University Health Center Campus
- Danville Regional Medical Center
- Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
- St. Mary's Regional Cancer Center at St. Mary's Medical Center