We have initiated a Phase I, dose-escalation trial of imetelstat (GRN163L) in patients with Chronic Lymphoproliferative Disease. The trial is primarily designed to demonstrate the safety and tolerability of imetelstat administered intravenously on a weekly basis. Importantly, Chronic Lymphoproliferative Disease also provides a unique opportunity to measure both the magnitude and time course of telomerase inhibition in tumor cells achieved at various doses of imetelstat. By serially assessing the effects of the drug on the target enzyme in cells, insights will be gained regarding the dose and dosing interval that optimally inhibits telomerase activity in the tumor. In this way, pharmacokinetic and pharmacodynamic parameters can be correlated with any observed reduction in patients' tumor burden.
This trial is closed to patient enrollment, but is active at the following sites:
Long Island Jewish Medical Center
New Hyde Park, NY
Nancy Driscoll, RN
Telephone: 718-470-4760
Weill Medical College of Cornell University
New York, NY
Patricia Glen, RN
Telephone: 212-746-6738
Roswell Park Cancer Institute
Buffalo, NY
Amy Whitworth
Telephone: 716-845-8965
Rocky Mountain Cancer Center
Denver, CO
Karen Morris
Telephone: 303-285-5004
Hackensack University Medical Center
Hackensack, NJ
Peggy Ford, MSN
Telephone: 201-336-8612
ClinWorks Cancer Research Center
Charlotte, NC
Elizabeth Marx
Telephone: 704-333-1555 ext. 112
University of Texas Southwestern
Harold C. Simmons Comprehensive Cancer Center
Dallas, TX
Tracee Rainey, RN
Telephone: 214-648-5102
University of Texas Health Science Center
San Antonio, TX
Stephanie Hodges, RN
Telephone: 210-746-0026
Solid Tumor Malignancies
This Phase I, dose-escalation trial of imetelstat (GRN163L) is primarily designed to demonstrate the safety and tolerability of administered intravenously (IV) on different schedules in patients with refractory or relapsed solid tumor malignancies. This study will also enable an assessment of the pharmacokinetic profile of GRN163L at escalating doses. A secondary endpoint of the trial is the preliminary evaluation of anti-tumor activity of imetelstat in this patient population.
This trial is open for patient enrollment at the following sites:
The University of Chicago Medical Center
Chicago, IL
Linda Janisch, RN, MS, OCN
Telephone: 773-702-1612
Wayne State University
Karmanos Cancer Center
Detroit, MI
Lisa Kolomyski
Telephone: 313-576-9386
Non-Small Cell Lung Cancer
Geron has initiated two clinical trials of imetelstat in patients with NSCLC.
The Phase II study is to evaluate the efficacy and safety of imetelstat (GRN163L) as maintenance therapy for patients with advanced stage NSCLC who have not progressed after 4 cycles of platinum based therapy. Participants will be randomized in a 2:1 ratio to imetelstat plus standard of care vs. standard of care alone. Participants who received bevacizumab with their induction chemotherapy will continue to receive bevacizumab on this study.
For further information about this study including participating sites and contact information, please visit the U.S. National Library of Medicine website at http://www.clinicaltrials.gov
The Phase I study in patients with advanced non-small cell lung cancer (NSCLC) is designed to determine the safety and maximum tolerated dose of imetalstat (GRN163L) when administered intravenously in combination with a standard paclitaxel and carboplatin regimen.
The trial is closed to patient enrollment, but is active at the following sites:
University of Texas
Simmons Comprehensive Cancer Center
Dallas, TX
Erin Fenske
Telephone: 214-648-1688
University of Wisconsin
Madison, WI
Sarah Marcotte
Telephone: 608-262-8158
University of Maryland Greenebaum Cancer Center
Baltimore, MD
R. Zak, RN, M.Ed.
Telephone: 410 328-9166
MD Anderson Cancer Center
Houston, TX
Roy Herbst, MD, PhD
Telephone: 713-792-6363
Multiple Myeloma
Geron has initiated two clinical trials in patients with multiple myeloma.
The first is a Phase I study to determine the safety and maximum tolerated dose (MTD) of imetelstat (GRN163L) when administered intravenously in patients with multiple myeloma who have received at least two prior regimens of treatment.
The trial is closed to patient enrollment, but is active at the following sites:
Roswell Park Cancer Institute
Buffalo, NY
Debbie Manfredi
Telephone: 716-845-3824
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore, MD
Dionne Savage, RN, BSN
Telephone: 410-614-0382
Dana Farber Cancer Institute
Boston, MA
Nikhil Munshi, MD
Telephone: 617-632-4218
The second clinical trial is a Phase I dose escalation study to determine the safety, maximum tolerated dose (MTD) and objective response rate of imetelstat (GRN163L) when administered intravenously in combination with bortezomib (Velcade®) with and without dexamethasone in patients with relapsed and refractory disease.
The trial is closed to patient enrollment, but it active at the following sites:
Fred Hutchinson Cancer Research Center
Seattle, WA
Kathy Lilleby
Telephone: 206-667-5836
Hackensack University Medical Center
Hackensack, NJ
Danielle Schillen, RN
Telephone: 201-336-8849
St. Vincent's Comprehensive Cancer Center
New York, NY
Ann Marshak
Telephone: 212-367-0195
University of Texas Health Science Center
San Antonio, TX
Stephanie Hodges
Telephone: 210-450-1804
Karmanos Cancer Center
Detroit, MI
Zhiwei Sun
Email: sunz@karmanos.org
Breast Cancer
The primary objective of the Phase I/II, dose escalation study is to determine the safety, maximum tolerated dose (MTD) and objective response rate of imetelstat (GRN163L) when administered intravenously in combination with a paclitaxel/bevacizumab regimen.
The trial is open for patient enrollment at the following site:
Melvin and Bren Simon Cancer Center at Indiana University
Indianapolis, IN
Kathy D. Miller, MD
Telephone: 317-274-1690
Ingalls Memorial Hospital
Harvey, IL
Patricia Gowland
Telephone: 708-915-6849
For a brief synopsis of the imetelstat (GRN163L) clinical trials, visit the U.S. National Library of Medicine website at http://www.clinicaltrials.gov
