Imetelstat Sodium in Treating Young Patients With Refractory or Recurrent Solid Tumors or Lymphoma
- Conditions
- Brain and Central Nervous System TumorsLymphomaLymphoproliferative DisorderSmall Intestine CancerUnspecified Childhood Solid Tumor, Protocol Specific
- Interventions
- Registration Number
- NCT01273090
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment imetelstat sodium - Treatment laboratory biomarker analysis - Treatment pharmacological study -
- Primary Outcome Measures
Name Time Method Maximum-tolerated dose and/or recommended phase II dose of imetelstat sodium in children with refractory or recurrent solid tumors or lymphoma 21 Days Toxicities of imetelstat sodium Up to 30 days post-treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Knight Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸St. Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
🇺🇸Atlanta, Georgia, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸New York, New York, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Baylor University Medical Center - Houston
🇺🇸Houston, Texas, United States
UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
🇺🇸Bethesda, Maryland, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Riley's Children Cancer Center at Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States