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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00117975
Other study ID # CALGB-50402
Secondary ID U10CA031946CDR00
Status Completed
Phase Phase 2
First received July 8, 2005
Last updated July 1, 2016
Start date June 2005
Est. completion date August 2013

Study information

Verified date July 2016
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
galiximab
given IV
rituximab
Given IV

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response complete and partial response will be assessed 12 months No
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