Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geron Corporation
ClinicalTrials.gov Identifier:
NCT00124189
First received: July 25, 2005
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Chronic Lymphoproliferative Diseases
Drug: GRN163L
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Chronic Lymphoproliferative Disease

Resource links provided by NLM:


Further study details as provided by Geron Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK and PD [ Time Frame: Measured in the first 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: July 2005
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
open label
Sequential dose cohort, open label, escalation trial evaluating one infusion duration of 2 hours
Drug: GRN163L
Weekly intravenous infusion

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Male or female
  • Chronic lymphoproliferative disease with related biology or similar clinical pattern to B-Cell Leukemia (CLL)including: small lymphocytic lymphoma (SLL), T cell prolymophocytic leukemia (T-PLL), B cell prolymphocytic leukemia (B-PLL), mantle cell lymphoma or other non-Hodgkins lymphoma in leukemic phase (peripheral blood circulating malignant cells present), Waldenstrom's macroglobulinemia
  • Must have relapsed from or be refractory to prior therapeutic regimens
  • Patients with CLL or SLL must have received at least one prior purine analogue-based chemotherapy regimen (eg, fludarabine, pentostatin or cladribine)
  • If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction > 50%
  • ECOG performance status 0-2
  • Life expectancy 3 months or greater

Exclusion Criteria:

  • Pregnant or lactating women
  • Active 2nd malignancy or history of another malignancy within 2 years, except:treated, non-melanoma skin cancer,treated breast or cervical carcinoma in situ,or resected T1a or b prostate cancer
  • Chemotherapeutic agents within 4 weeks prior to study
  • High dose CTX with stem cell support within 6 months prior to study
  • Signal transduction inhibitors,or monoclonal antibodies within 4 weeks prior to study
  • Immunotherapy or biological response modifiers within 4 weeks prior to study
  • Systemic hormonal therapy within 4 weeks prior to study
  • Anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study
  • Radiotherapy within 4 weeks prior to study
  • Active autoimmune disorder
  • Central nervous system or leptomeningeal involvement
  • Clinically significant cardiovascular disease
  • Known HIV infection
  • Serious/active infection
  • Surgical procedure within 2 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124189

Locations
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Center
Buffalo, New York, United States, 14263
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, Ohio
The Ohio State University James Cancer Hospital
Columbus, Ohio, United States, 43210
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Geron Corporation
Investigators
Study Director: Stephen Kelsey, MD Geron Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Geron Corporation
ClinicalTrials.gov Identifier: NCT00124189     History of Changes
Other Study ID Numbers: GRN163L CP04-151
Study First Received: July 25, 2005
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Geron Corporation:
Chronic lymphocytic leukemia
T-cell prolymphocytic leukemia
Chronic lymphoproliferative diseases
Telomerase
Telomerase Inhibition

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014