SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

March 5, 2018

Primary Completion Date

September 30, 2022

Study Completion Date

May 24, 2024

Conditions
Anaplastic AstrocytomaAnaplastic EpendymomaAnaplastic GangliogliomaAnaplastic MeningiomaAnaplastic OligodendrogliomaPleomorphic Xanthoastrocytoma, AnaplasticAtypical Teratoid/Rhabdoid TumorBrain CancerBrain TumorCentral Nervous System NeoplasmsChoroid Plexus CarcinomaCNS Embryonal Tumor With Rhabdoid FeaturesGanglioneuroblastoma of Central Nervous SystemCNS TumorEmbryonal Tumor of CNSEpendymomaGlioblastomaGliomaGlioma, MalignantMedulloblastomaMedulloblastoma; Unspecified SiteMedulloepitheliomaNeuroepithelial TumorNeoplasmsNeoplasms, NeuroepithelialPapillary Tumor of the Pineal Region (High-grade Only)Pediatric Brain TumorPineal Parenchymal Tumor of Intermediate Differentiation (High-grade Only)PineoblastomaPrimitive Neuroectodermal TumorRecurrent MedulloblastomaRefractory Brain TumorNeuroblastoma. CNSGlioblastoma, IDH-mutantGlioblastoma, IDH-wildtypeMedulloblastoma, Group 3Medulloblastoma, Group 4Glioma, High GradeNeuroepithelial Tumor, High GradeMedulloblastoma, SHH-activated and TP53 MutantMedulloblastoma, SHH-activated and TP53 WildtypeMedulloblastoma, Chromosome 9q LossMedulloblastoma, Non-WNT Non-SHH, NOSMedulloblastoma, Non-WNT/Non-SHHMedulloblastoma, PTCH1 MutationMedulloblastoma, WNT-activatedEpendymoma, RecurrentGlioma, Recurrent High GradeGlioma, Recurrent MalignantEmbryonal Tumor, NOSGlioma, Diffuse Midline, H3K27M-mutantEmbryonal Tumor With Multilayered Rosettes (ETMR)Ependymoma, NOS, WHO Grade IIIEpendymoma, NOS, WHO Grade IIMedulloblastoma, G3/G4Ependymoma, RELA Fusion Positive
Interventions
DRUG

Gemcitabine

Given intravenously (IV).

DRUG

ribociclib

Given orally (PO).

DRUG

sonidegib

Given PO.

DRUG

trametinib

Given PO.

BIOLOGICAL

filgrastim

Given subcutaneously (SQ).

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

St. Jude Children's Research Hospital

OTHER