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A Study of Pomalidomide Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors

Medulloblastoma Clinical Trial

Official title:
A PHASE 2 CLINICAL STUDY OF POMALIDOMIDE (CC-4047) MONOTHERAPY FOR CHILDREN AND YOUNG ADULTS WITH RECURRENT OR PROGRESSIVE PRIMARY BRAIN TUMORS

Clinical Trial Summary

This study will assess the efficacy, safety and tolerability of pomalidomide in children and young adults aged 1 to < 21 years with recurrent or progressive primary brain tumors in one of four primary brain tumor types: high-grade glioma (HGG), medulloblastoma, ependymoma and diffuse intrinsic pontine glioma (DIPG).

Clinical Trial Description

The study will consist of 4 parallel groups of participants, one for each of the following primary brain tumor types: high-grade glioma, medulloblastoma, ependymoma and DIPG. A Simon's Optimal two-stage study design will be applied to each group and enrollment will occur as follows: - Stage 1: Nine participants will be enrolled in each brain tumor type group - Stage 2: If during Stage 1, ≥ 2 participants achieves either an objective response (either complete response or partial response) within the first 6 cycles of treatment (or within the first 3 cycles for DIPG participants), or a long-term stable disease, an additional 11 participants shall be enrolled; otherwise no additional participants will be enrolled into that group. - If a total of 5 or more participants across all 20 participants in a given group (Stage 1 and 2) evaluable for the primary endpoint are observed as having either an objective response (either complete response or partial response) within the first 6 cycles of treatment (or within the first 3 cycles for DIPG participants) or a long-term stable disease, pomalidomide will be considered effective in that disease indication. Once treatment has been discontinued, participants will be followed up for up to 5 years from enrollment of the last participant. Participants who withdraw from either stage for reasons other than disease progression prior to completing Cycle 1 of study treatment will be replaced. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03257631
Study type Interventional
Source Celgene
Contact
Status Completed
Phase Phase 2
Start date September 18, 2017
Completion date September 14, 2023
View Details
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