Diffuse Intrinsic Pontine Glioma Clinical Trial
Official title:
Phase I Trial of Panobinostat in Children With Diffuse Intrinsic Pontine Glioma
This phase I trial studies the side effects and best dose of panobinostat in treating younger patients with diffuse intrinsic pontine glioma that is growing, spreading, or getting worse (progressive). Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To describe the toxicity profile and define the dose-limiting toxicities of panobinostat
in children with recurrent/progressive diffuse intrinsic pontine glioma (DIPG).
II. To estimate the maximum-tolerated dose and/or the recommended-phase 2 dose of
panobinostat in children with recurrent/progressive DIPG.
III. To evaluate and characterize the plasma pharmacokinetics of panobinostat in children
with recurrent/progressive DIPG.
SECONDARY OBJECTIVES:
I. To describe the progression-free survival (PFS) and overall survival (OS) of children
with recurrent or progressive DIPG who are treated with panobinostat.
II. To identify histone 3 K27M mutations in peripheral blood and urine, and evaluate changes
with treatment.
OUTLINE: This is a dose-escalation study.
Patients receive panobinostat orally (PO) thrice weekly for 3 weeks. Treatment repeats every
28 days for 26 courses (2 years) in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up for 30 days and then every 3
months for 3 years.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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