Lymphoma Clinical Trial
Official title:
A Phase II Trial of Extended Induction Galiximab (Anti-CD80 Monoclonal Antibody) (IND #12373) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)
RATIONALE: Monoclonal antibodies, such as rituximab and galiximab, 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. Giving more than
one monoclonal antibody may be a better way to block cancer growth.
PURPOSE: This phase II trial is studying how well giving rituximab together with galiximab
works in treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.
Status | Completed |
Enrollment | 62 |
Est. completion date | August 2013 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
1. 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). 2. 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 3. Age - Patients must be = 18 years of age 4. ECOG Performance Status - Patients must have ECOG Performance Status 0-2. 5. 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). 6. CNS Involvement - Patients must have no known CNS involvement by lymphoma. 7. 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. 8. Human Anti-Chimeric Antibody - Patients must have no known baseline human anti-chimeric antibody (HACA) positivity. 9. 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). 10. 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. 11. 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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | CancerCare of Maine at Eastern Maine Medial Center | Bangor | Maine |
United States | Mountainview Medical | Berlin | Vermont |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont |
United States | Graham Hospital | Canton | Illinois |
United States | Memorial Hospital | Carthage | Illinois |
United States | Iowa Blood and Cancer Care | Cedar Rapids | Iowa |
United States | Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa |
United States | St. Luke's Hospital | Cedar Rapids | Iowa |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri |
United States | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus | Ohio |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | Eureka Community Hospital | Eureka | Illinois |
United States | McLeod Regional Medical Center | Florence | South Carolina |
United States | Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida |
United States | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana |
United States | Galesburg Clinic | Galesburg | Illinois |
United States | Galesburg Cottage Hospital | Galesburg | Illinois |
United States | CaroMont Cancer Center at Gaston Memorial Hospital | Gastonia | North Carolina |
United States | Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls | New York |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Wayne Radiation Oncology | Goldsboro | North Carolina |
United States | Bon Secours St. Francis Health System | Greenville | South Carolina |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | Mason District Hospital | Havana | Illinois |
United States | Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida |
United States | New Hampshire Oncology-Hematology, PA - Hooksett | Hooksett | New Hampshire |
United States | Hopedale Medical Complex | Hopedale | Illinois |
United States | St. Mary's Regional Cancer Center at St. Mary's Medical Center | Huntington | West Virginia |
United States | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa |
United States | Capital Region Cancer Center | Jefferson City | Missouri |
United States | Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida |
United States | Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene | New Hampshire |
United States | Kewanee Hospital | Kewanee | Illinois |
United States | Lenoir Memorial Cancer Center | Kinston | North Carolina |
United States | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | McDonough District Hospital | Macomb | Illinois |
United States | Elliot Regional Cancer Center | Manchester | New Hampshire |
United States | Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville | Virginia |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota |
United States | Long Island Jewish Medical Center | New Hyde Park | New York |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | New York Weill Cornell Cancer Center at Cornell University | New York | New York |
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 | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois |
United States | Proctor Hospital | Peoria | Illinois |
United States | Illinois Valley Community Hospital | Peru | Illinois |
United States | Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania |
United States | Perry Memorial Hospital | Princeton | Illinois |
United States | Frisbie Memorial Hospital | Rochester | New Hampshire |
United States | St. Margaret's Hospital | Spring Valley | Illinois |
United States | Siteman Cancer Center at Barnes-Jewish Hospital | St Louis | Missouri |
United States | Missouri Baptist Cancer Center | St. Louis | Missouri |
United States | CCOP - Hematology-Oncology Associates of Central New York | Syracuse | New York |
United States | Community General Hospital of Greater Syracuse | Syracuse | New York |
United States | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington | District of Columbia |
United States | Wilson Medical Center | Wilson | North Carolina |
United States | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina |
United States | UMASS Memorial Cancer Center - University Campus | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Czuczman MS, Leonard JP, Johnson JL, et al.: FLIPI score is applicable and predictive of response to upfront immunotherapy in CALGB 50402: phase II trial of extended induction galiximab ([G] anti-CD80 monoclonal antibody) plus rituximab [R]. [Abstract] Bl
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---|---|---|---|---|
Primary | Overall response | complete and partial response will be assessed | 12 months | No |
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