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Trial of Panobinostat in Children With Diffuse Intrinsic Pontine Glioma

NCT02717455 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2024-04-25

Study results available
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Summary

This phase I trial studies the side effects and best dose of panobinostat in treating younger patients with diffuse intrinsic pontine glioma (DIPG). Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stratum 1 treats patients with DIPG that has returned or gotten worse (progressed). Stratum 2 treats patients with DIPG or H3K27+Thalamic Diffuse Malignant Glioma (DMG) that has not yet gotten worse.

Conditions

Interventions

DRUG

LBH589

STRATUM 1: Recurrent/progressive DIPG. Panobinostat will be given every other day, 3 times/ week, p.o. preferably on Mon/Wed/Fri, for three weeks, followed by one week off of therapy. Three weeks of therapy plus the one week rest period (4 weeks) will constitute one course. Treatment will continue for up to 26 courses (about 2 years) barring progressive disease or unacceptable toxicity. STRATUM 2: Non-progressed DIPG or H3K27M+ Thalamic DMG. Panobinostat will be given every other day, 3 times/week, every other week p.o. preferably on Mon/Wed/Fri. Four weeks will constitute one course. Treatment will continue for up to 26 courses (about 2 years) unless the patient experiences progressive disease, unacceptable toxicity or any of the off-treatment criteria.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Pediatric Brain Tumor Consortium

    lead NETWORK

Principal Investigators

  • Michelle Monje, MD, Phd · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-28
Primary Completion
2022-02-14
Completion
2024-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02717455 on ClinicalTrials.gov