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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.
First Received: July 8, 2005   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00117975
  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 II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Rituximab Galiximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
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)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response (complete and partial) at 12 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Time to best response [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: June 2005
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117975

  Show 68 Study Locations
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.

Study ID Numbers: CDR0000433340, CALGB-50402
Study First Received: July 8, 2005
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00117975     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Lymphoma, Follicular
Follicular Lymphoma
Lymphoma, Small Cleaved-cell, Diffuse
Antibodies, Monoclonal
Lymphatic Diseases
Antibodies
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Lymphoma, Follicular
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009