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

NCT ID: NCT00117975

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2013-08-31

Brief Summary

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.

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

galiximab

given IV

Intervention Type: BIOLOGICAL

rituximab

Given IV

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myron S. Czuczman, MD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Locations

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, United States

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, United States

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, United States

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Graham Hospital

Canton, Illinois, United States

Memorial Hospital

Carthage, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Eureka Community Hospital

Eureka, Illinois, United States

Galesburg Clinic

Galesburg, Illinois, United States

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Mason District Hospital

Havana, Illinois, United States

Hopedale Medical Complex

Hopedale, Illinois, United States

Kewanee Hospital

Kewanee, Illinois, United States

McDonough District Hospital

Macomb, Illinois, 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

Proctor Hospital

Peoria, Illinois, United States

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Illinois Valley Community Hospital

Peru, Illinois, United States

Perry Memorial Hospital

Princeton, Illinois, United States

St. Margaret's Hospital

Spring Valley, Illinois, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Iowa Blood and Cancer Care

Cedar Rapids, Iowa, United States

St. Luke's Hospital

Cedar Rapids, Iowa, United States

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, United States

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

CancerCare of Maine at Eastern Maine Medial Center

Bangor, Maine, United States

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, United States

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, United States

Capital Region Cancer Center

Jefferson City, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, United States

Missouri Baptist Cancer Center

St Louis, Missouri, United States

New Hampshire Oncology-Hematology, PA - Hooksett

Hooksett, New Hampshire, United States

Kingsbury Center for Cancer Care at Cheshire Medical Center

Keene, New Hampshire, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Elliot Regional Cancer Center

Manchester, New Hampshire, United States

Frisbie Memorial Hospital

Rochester, New Hampshire, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Charles R. Wood Cancer Center at Glens Falls Hospital

Glens Falls, New York, 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

CCOP - Hematology-Oncology Associates of Central New York

Syracuse, New York, United States

Community General Hospital of Greater Syracuse

Syracuse, New York, United States

CaroMont Cancer Center at Gaston Memorial Hospital

Gastonia, North Carolina, United States

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Wayne Radiation Oncology

Goldsboro, North Carolina, United States

Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Lenoir Memorial Cancer Center

Kinston, North Carolina, United States

Wilson Medical Center

Wilson, North Carolina, United States

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, United States

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

McLeod Regional Medical Center

Florence, South Carolina, United States

Bon Secours St. Francis Health System

Greenville, South Carolina, United States

CCOP - Greenville

Greenville, South Carolina, United States

Mountainview Medical

Berlin Corners, Vermont, United States

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, United States

Danville Regional Medical Center

Danville, Virginia, United States

Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

Martinsville, Virginia, United States

St. Mary's Regional Cancer Center at St. Mary's Medical Center

Huntington, West Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

Lansigan F, Barak I, Pitcher B, Jung SH, Cheson BD, Czuczman M, Martin P, Hsi E, Schoder H, Smith S, Bartlett NL, Leonard JP, Blum KA. The prognostic significance of PFS24 in follicular lymphoma following firstline immunotherapy: A combined analysis of 3 CALGB trials. Cancer Med. 2019 Jan;8(1):165-173. doi: 10.1002/cam4.1918. Epub 2018 Dec 21.

Reference Type: DERIVED

PMID: 30575311 (View on PubMed)

Other Identifiers

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000433340

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-50402

Identifier Type: -

Identifier Source: org_study_id