The purpose of this study is to determine whether anti-CD80 monoclonal antibody (IDEC-114) is effective in the treatment of follicular B-cell non-Hodgkin's lymphoma. This drug has never been studied in patients with lymphoma, however, it has been studied in psoriasis patients at various dose levels and schedules.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Phase 1-A Group 1 - 125 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-A Group 2 - 250 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-A Group 3 - 375 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-B Group 4 - 500 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase II-A \& II-B - Dosage start at the MTD (up to 375 mg/m2)
Research Site
Tucson, Arizona, United States
Research Site
Rochester, Minnesota, United States
Research Site
Buffalo, New York, United States
Research Site
Durham, North Carolina, United States
To characterize the safety profile of IDEC-114 and to define their duration and reversibility
Time frame: March 2010
To evaluate PK
Time frame: March 2010
To monitor presence of human anti galiximab antibody
Time frame: March 2010
To evaluate efficacy
Time frame: March 2010
To identify Nk functional assays that may predict galiximab efficacy
Time frame: March 2010
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