Rhabdomyosarcoma Clinical Trial
Official title:
A Phase II Study of Imetelstat (GRN163L, NSC# 754228) in Children With Relapsed or Refractory Solid Tumors
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.
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.
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