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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02011126
Study type Interventional
Source Children's Oncology Group
Contact
Status Withdrawn
Phase Phase 2
Start date June 30, 2014

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