To determine what side effects and what clinical effect, if any, the administration of this investigational product, IDEC-114 in combination with Rituxan® \[Rituxan® as a single agent is approved by the United States Food and Drug Administration (FDA) to treat patients with relapsed or refractory follicular NHL\], has in this patient population.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Dose Group 1 - 125 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 2 - 250 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 3 - 375 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 4 - 500 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions
Research site
Birmingham, Alabama, United States
Research site
Tucson, Arizona, United States
To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study
Time frame: March 2010
To evaluate PK
Time frame: March 2010
To evaluate efficacy
Time frame: March 2010
To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation
Time frame: March 2010
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Research site
Los Angeles, California, United States
Research site
Newport Beach, California, United States
Research site
San Diego, California, United States
Research site
Aurora, Colorado, United States
Research site
Washington D.C., District of Columbia, United States
Research site
Tampa Bay, Florida, United States
Research site
Chicago, Illinois, United States
Research site
Maywood, Illinois, United States
...and 12 more locations