Rituximab and Galiximab in Treating Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00117975
First received: July 8, 2005
Last updated: March 15, 2012
Last verified: March 2011
  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)

Resource links provided by NLM:


Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Biological: galiximab
    given IV
    Biological: rituximab
    Given IV
Detailed Description:

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117975

  Hide Study Locations
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
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Myron S. Czuczman, MD Roswell Park Cancer Institute
  More Information

Additional Information:
Publications:
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] Blood 112 (11): A-1003, 2008.

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
Antibodies, Monoclonal
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 23, 2014