Rituximab and Galiximab in Treating Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: galiximab Biological: rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Extended Induction Galiximab (Anti-CD80 Monoclonal Antibody) (IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL) |
- Overall response [ Time Frame: 12 months ] [ Designated as safety issue: No ]complete and partial response will be assessed
| Enrollment: | 62 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | March 2017 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
-
Biological: galiximab
OBJECTIVES:
Primary
- Determine the overall and complete response rate in patients with previously untreated CD20-positive bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma treated with rituximab and galiximab.
- Determine the time to disease progression in patients treated with this regimen.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Correlate Fc receptor polymorphism profiling with response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy (month 1): Patients receive rituximab IV on days 1, 8, 15, and 22 and galiximab IV over 1 hour on day 3, 8, 15, and 22.
- Extended induction therapy (months 3, 5, 7, and 9): Beginning in month 3, patients receive rituximab and galiximab as above on day 1. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 4 months for up to 10 years.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* previously untreated follicular non-Hodgkin's lymphoma (NHL), meeting 1 of the following stage criteria:
- Bulky stage II disease (i.e., at least 1 unidimensionally measurable mass ≥ 7 cm)
- Stage III or IV disease NOTE: *Bone marrow biopsy as the sole means of diagnosis is not acceptable; fine needle aspiration is not acceptable
- WHO grade 1, 2, or 3a disease (i.e., > 15 centroblasts per high power field with centrocytes present)
- CD20-positive disease by flow cytometry or immunohistochemistry
Measurable disease by physical examination or imaging studies
- Tumor mass > 1 cm
Patients with only nonmeasurable disease are not eligible
The following are considered nonmeasurable disease:
- Bone lesions
- Ascites
- Pleural or pericardial effusion
- Lymphangitis cutis or pulmonis
- Bone marrow lesions
- No known CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 50,000/mm^3
Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN)* NOTE: *Unless due to lymphoma or Gilbert's disease
Renal
- Creatinine ≤ 2 times ULN* NOTE: *Unless due to lymphoma
Immunologic
No known HIV positivity
- HIV negative (for patients with a history of IV drug abuse or any behavior associated with an increased risk for HIV infection)
- No known human anti-chimeric antibody positivity
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No other currently active* malignancy (including Waldenstrom's macroglobulinemia) except nonmelanoma skin cancer NOTE: *Patients who have completed prior anticancer therapy AND have < 30% risk for relapse are not considered to have a currently active malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior immunotherapy (e.g., monoclonal antibody-based therapy) for NHL
Chemotherapy
- No prior chemotherapy for NHL
- No concurrent chemotherapy
Endocrine therapy
- More than 2 weeks since prior corticosteroids except as maintenance therapy for a non-malignant disease
- No concurrent hormonal therapy except steroids for adrenal failure OR hormones for non-disease-related conditions (e.g., insulin for diabetes)
No concurrent dexamethasone or other steroidal antiemetics except for the following circumstances:
- Acute grade 3 or 4 monoclonal antibody-associated infusion reaction not responsive to transient discontinuation of antibody infusion or acetaminophen and diphenhydramine
- Retreatment after an infusion reaction
Radiotherapy
- No prior radiotherapy for NHL
Surgery
- Not specified
Contacts and Locations
Hide Study Locations| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Memorial Cancer Institute at Memorial Regional Hospital | |
| Hollywood, Florida, United States, 33021 | |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | |
| Jupiter, Florida, United States, 33458 | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Illinois | |
| Graham Hospital | |
| Canton, Illinois, United States, 61520 | |
| Memorial Hospital | |
| Carthage, Illinois, United States, 62321 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Eureka Community Hospital | |
| Eureka, Illinois, United States, 61530 | |
| Galesburg Cottage Hospital | |
| Galesburg, Illinois, United States, 61401 | |
| Galesburg Clinic | |
| Galesburg, Illinois, United States, 61401 | |
| Mason District Hospital | |
| Havana, Illinois, United States, 62644 | |
| Hopedale Medical Complex | |
| Hopedale, Illinois, United States, 61747 | |
| Kewanee Hospital | |
| Kewanee, Illinois, United States, 61443 | |
| McDonough District Hospital | |
| Macomb, Illinois, United States, 61455 | |
| Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| BroMenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Community Hospital of Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Cancer Treatment Center at Pekin Hospital | |
| Pekin, Illinois, United States, 61554 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| Illinois Valley Community Hospital | |
| Peru, Illinois, United States, 61354 | |
| Perry Memorial Hospital | |
| Princeton, Illinois, United States, 61356 | |
| St. Margaret's Hospital | |
| Spring Valley, Illinois, United States, 61362 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology | |
| Fort Wayne, Indiana, United States, 46815 | |
| United States, Iowa | |
| Mercy Regional Cancer Center at Mercy Medical Center | |
| Cedar Rapids, Iowa, United States, 52403 | |
| Iowa Blood and Cancer Care | |
| Cedar Rapids, Iowa, United States, 52402 | |
| St. Luke's Hospital | |
| Cedar Rapids, Iowa, United States, 52402 | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maine | |
| CancerCare of Maine at Eastern Maine Medial Center | |
| Bangor, Maine, United States, 04401 | |
| United States, Massachusetts | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Minnesota | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Capital Region Cancer Center | |
| Jefferson City, Missouri, United States, 65101 | |
| Siteman Cancer Center at Barnes-Jewish Hospital | |
| St Louis, Missouri, United States, 63110 | |
| Missouri Baptist Cancer Center | |
| St. Louis, Missouri, United States, 63131 | |
| United States, New Hampshire | |
| New Hampshire Oncology-Hematology, PA - Hooksett | |
| Hooksett, New Hampshire, United States, 03106 | |
| Kingsbury Center for Cancer Care at Cheshire Medical Center | |
| Keene, New Hampshire, United States, 03431 | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Elliot Regional Cancer Center | |
| Manchester, New Hampshire, United States, 03103 | |
| Frisbie Memorial Hospital | |
| Rochester, New Hampshire, United States, 03867 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Charles R. Wood Cancer Center at Glens Falls Hospital | |
| Glens Falls, New York, United States, 12801 | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11042 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| CCOP - Hematology-Oncology Associates of Central New York | |
| Syracuse, New York, United States, 13057 | |
| Community General Hospital of Greater Syracuse | |
| Syracuse, New York, United States, 13215 | |
| United States, North Carolina | |
| CaroMont Cancer Center at Gaston Memorial Hospital | |
| Gastonia, North Carolina, United States, 28053 | |
| Wayne Radiation Oncology | |
| Goldsboro, North Carolina, United States, 27534 | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27534 | |
| Pardee Memorial Hospital | |
| Hendersonville, North Carolina, United States, 28791 | |
| Lenoir Memorial Cancer Center | |
| Kinston, North Carolina, United States, 28501 | |
| Wilson Medical Center | |
| Wilson, North Carolina, United States, 27893-3428 | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| United States, Pennsylvania | |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224-1791 | |
| United States, South Carolina | |
| McLeod Regional Medical Center | |
| Florence, South Carolina, United States, 29501 | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| Bon Secours St. Francis Health System | |
| Greenville, South Carolina, United States, 29601 | |
| United States, Vermont | |
| Mountainview Medical | |
| Berlin, Vermont, United States, 05602 | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Danville Regional Medical Center | |
| Danville, Virginia, United States, 24541 | |
| Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | |
| Martinsville, Virginia, United States, 24115 | |
| United States, West Virginia | |
| St. Mary's Regional Cancer Center at St. Mary's Medical Center | |
| Huntington, West Virginia, United States, 25702 | |
| Study Chair: | Myron S. Czuczman, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00117975 History of Changes |
| Other Study ID Numbers: | CDR0000433340, U10CA031946, CALGB-50402 |
| Study First Received: | July 8, 2005 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cancer and Leukemia Group B:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013