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Imetelstat Sodium in Treating Young Patients With Refractory or Recurrent Solid Tumors or Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01273090
First Posted: January 10, 2011
Last Update Posted: January 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose

RATIONALE: Imetelstat sodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I clinical trial is studying the side effects and best dose of imetelstat sodium in treating young patients with refractory or recurrent solid tumors or lymphoma.


Condition Intervention Phase
Brain and Central Nervous System Tumors Lymphoma Lymphoproliferative Disorder Small Intestine Cancer Unspecified Childhood Solid Tumor, Protocol Specific Drug: imetelstat sodium Other: laboratory biomarker analysis Other: pharmacological study Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Imetelstat, a Telomerase Inhibitor, in Children With Refractory or Recurrent Solid Tumors and Lymphomas

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Maximum-tolerated dose and/or recommended phase II dose of imetelstat sodium in children with refractory or recurrent solid tumors or lymphoma [ Time Frame: 21 Days ]
  • Toxicities of imetelstat sodium [ Time Frame: Up to 30 days post-treatment ]

Enrollment: 34
Study Start Date: May 2011
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: imetelstat sodium Other: laboratory biomarker analysis Other: pharmacological study

Detailed Description:

OBJECTIVES:

Primary

  • To estimate the maximum-tolerated dose (MTD) and/or recommended phase II dose of imetelstat sodium in children with refractory or recurrent solid tumors or lymphoma.
  • To define and describe the toxicities of imetelstat sodium.
  • To characterize the pharmacokinetics of imetelstat sodium in children with refractory or recurrent solid tumors or lymphoma.

Secondary

  • To determine, in a preliminary manner, the antitumor effects of imetelstat sodium in children with refractory or recurrent solid tumors or lymphoma. (exploratory)
  • To provide preliminary assessment of the biological activity of imetelstat sodium in children with recurrent or refractory malignancies by assessing telomerase activity, telomere length, hTERT protein, hTERT mRNA, and hTR levels in patient peripheral blood mononuclear cells (PBMNC) samples pretreatment and on treatment. (Exploratory)
  • To assess telomerase activity, hTERT expression, telomere length, hTERT protein, hTERT mRNA, and hTR levels in patients' pretreatment tumor samples. (Exploratory)

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive imetelstat sodium IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at baseline and periodically during study for pharmacokinetic and correlative studies. Tumor tissue samples from diagnosis and/or subsequent tumor resections or biopsies may also be collected for correlative studies.

After completion of study therapy, patients are followed up for 30 days.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of refractory or recurrent solid tumors, including lymphoma

    • No CNS tumors or known CNS metastases (Part A, dose escalation)
    • CNS tumors or known CNS metastases allowed (Part B, maximum-tolerated dose or recommended phase II dose)

      • No prior or concurrent CNS hemorrhage on a baseline MRI within the past 14 days
    • All patients must have histologic verification of malignancy at original diagnosis or relapse except for:

      • Intrinsic brain stem tumors
      • Optic pathway gliomas
      • Pineal tumors and elevations of CSF or serum tumor markers including alpha-fetoprotein or beta-HCG
  • Measurable or evaluable disease
  • Disease for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
  • Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood count criteria and they are not known to be refractory to red cell or platelet transfusions

PATIENT CHARACTERISTICS:

  • Karnofsky performance status (PS) 50-100% (patients > 16 years of age) OR Lansky PS 50-100% (patients ≤ 16 years of age)
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³ (transfusion-independent, defined as not receiving platelet transfusion within the past 7 days prior to enrollment)
  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR a serum creatinine based on age and/or gender as follows:

    • 0.6 mg/dL (1 to < 2 years of age)
    • 0.8 mg/dL (2 to < 6 years of age)
    • 1.0 mg/dL (6 to < 10 years of age)
    • 1.2 mg/dL (10 to < 13 years of age)
    • 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
    • 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
  • Bilirubin (sum of conjugated and unconjugated) ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 110 U/L (ULN for ALT is 45 U/L)
  • Serum albumin ≥ 2 g/dL
  • aPTT < 1.2 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use an effective contraception method
  • No uncontrolled infection
  • No patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

PRIOR CONCURRENT THERAPY:

  • Recovered from acute toxic effects of all prior anti-cancer chemotherapy, immunotherapy, or radiotherapy
  • At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea)
  • At least 14 days since prior long-acting growth factor (e.g., Neulasta) or ≥ 7 days since prior short-acting growth factor
  • At least 7 days since prior biologic or anti-neoplastic agent
  • At least 6 weeks since any type of prior immunotherapy (e.g., tumor vaccines)
  • At least 3 half-lives since last dose of a monoclonal antibody
  • At least 2 weeks since prior local palliative radiotherapy (small port)

    • At least 24 weeks since prior total-body irradiation, craniospinal radiotherapy, or radiation to ≥ 50% of the pelvis
    • At least 6 weeks since prior substantial bone marrow radiation
  • At least 12 weeks since prior transplantation or stem cell infusion with no evidence of active graft vs host disease
  • Prior and concurrent stable or decreasing dose of corticosteroids within the past 7 days allowed
  • No prior allogeneic transplant
  • No other concurrent investigational drug
  • No other concurrent anticancer agents including chemotherapy, radiotherapy, immunotherapy, or biologic therapy
  • No concurrent cyclosporine, tacrolimus, or other agents to prevent either graft-versus-host disease post-bone marrow transplant or organ rejection post-transplant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273090


  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, California
Children's Hospital of Orange County
Orange, California, United States, 92868
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States, 30322
United States, Illinois
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60611
United States, Indiana
Riley's Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 2115
United States, Michigan
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-0286
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St. Louis, Missouri, United States, 63110
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030-2399
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
United States, Wisconsin
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Patrick A. Thompson, MD Baylor College of Medicine
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01273090     History of Changes
Other Study ID Numbers: ADVL1112
COG-ADVL1112
First Submitted: January 7, 2011
First Posted: January 10, 2011
Last Update Posted: January 30, 2014
Last Verified: January 2014

Keywords provided by Children's Oncology Group:
unspecified childhood solid tumor, protocol specific
recurrent childhood anaplastic large cell lymphoma
recurrent childhood grade III lymphomatoid granulomatosis
recurrent childhood large cell lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent/refractory childhood Hodgkin lymphoma
recurrent childhood brain stem glioma
recurrent childhood anaplastic astrocytoma
recurrent childhood anaplastic oligoastrocytoma
recurrent childhood anaplastic oligodendroglioma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood diffuse astrocytoma
recurrent childhood fibrillary astrocytoma
recurrent childhood gemistocytic astrocytoma
recurrent childhood giant cell glioblastoma
recurrent childhood glioblastoma
recurrent childhood gliomatosis cerebri
recurrent childhood gliosarcoma
recurrent childhood oligoastrocytoma
recurrent childhood oligodendroglioma
recurrent childhood pilocytic astrocytoma
recurrent childhood pilomyxoid astrocytoma
recurrent childhood pleomorphic xanthoastrocytoma
recurrent childhood protoplasmic astrocytoma
recurrent childhood subependymal giant cell astrocytoma
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood visual pathway glioma
childhood pineal parenchymal tumor

Additional relevant MeSH terms:
Lymphoma
Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Lymphoproliferative Disorders
Intestinal Neoplasms
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Nervous System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Niacinamide
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs