Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02011126

Imetelstat Sodium in Treating Younger Patients With Relapsed or Refractory Solid Tumors

A Phase II Study of Imetelstat (GRN163L, NSC# 754228) in Children With Relapsed or Refractory Solid Tumors

Status
Withdrawn
Phase
Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Children's Oncology Group · Network
Sex
All
Age
1 Year – 30 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies the side effects and how well imetelstat sodium works in treating younger patients with relapsed or refractory solid tumors. Imetelstat sodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the objective response rate, defined as partial response or better, of imetelstat (imetelstat sodium) in children with relapsed or refractory solid tumors. II. To further define and describe the toxicities associated with imetelstat in children with recurrent/refractory solid tumors. SECONDARY OBJECTIVES: I. To determine the time to progression following treatment with imetelstat in children with relapsed or refractory solid tumors. TERTIARY OBJECTIVES: I. To measure tumor telomere length in archival samples, and to correlate telomere length to the clinical outcome of the study. OUTLINE: Patients receive imetelstat sodium intravenously (IV) over 2 hours on days 1 and 8. Treatment repeats every 21 days for up to 36 courses in the absence of disease progression or unacceptable toxicity.

Conditions

Interventions

TypeNameDescription
DRUGImetelstat SodiumGiven IV
OTHERLaboratory Biomarker AnalysisOptional correlative studies

Timeline

Start date
2014-06-30
Primary completion
2016-03-25
First posted
2013-12-13
Last updated
2018-08-07

Source: ClinicalTrials.gov record NCT02011126. Inclusion in this directory is not an endorsement.