The purpose of this study is to determine the safety and maximum tolerated dose of GRN163L in treating patients with refractory or relapsed chronic lymphoproliferative disease.
Imetelstat Sodium (GRN163L) is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects. High telomerase levels and short telomere lengths correlate with other markers of poor prognosis in patients with chronic lymphoproliferative disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Weekly intravenous infusion
Rocky Mountain Cancer Center
Denver, Colorado, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Center
Buffalo, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or recommended phase II dose of GRN163L in patients with relapsed or refractory chronic lymphoproliferative disease
Time frame: First 3 weeks
PK and PD
Time frame: Measured in the first 6 weeks
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Weill Medical College of Cornell University
New York, New York, United States
The Ohio State University James Cancer Hospital
Columbus, Ohio, United States
UT Southwestern
Dallas, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States