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

> **NCT03434262** · PHASE1 · COMPLETED · sponsor: **St. Jude Children's Research Hospital** · enrollment: 68 (actual)

## Conditions studied

- Anaplastic Astrocytoma
- Anaplastic Ependymoma
- Anaplastic Ganglioglioma
- Anaplastic Meningioma
- Anaplastic Oligodendroglioma
- Pleomorphic Xanthoastrocytoma, Anaplastic
- Atypical Teratoid/Rhabdoid Tumor
- Brain Cancer
- Brain Tumor
- Central Nervous System Neoplasms
- Choroid Plexus Carcinoma
- CNS Embryonal Tumor With Rhabdoid Features
- Ganglioneuroblastoma of Central Nervous System
- CNS Tumor
- Embryonal Tumor of CNS
- Ependymoma
- Glioblastoma
- Glioma
- Glioma, Malignant
- Medulloblastoma
- Medulloblastoma; Unspecified Site
- Medulloepithelioma
- Neuroepithelial Tumor
- Neoplasms
- Neoplasms, Neuroepithelial
- Papillary Tumor of the Pineal Region (High-grade Only)
- Pediatric Brain Tumor
- Pineal Parenchymal Tumor of Intermediate Differentiation (High-grade Only)
- Pineoblastoma
- Primitive Neuroectodermal Tumor
- Recurrent Medulloblastoma
- Refractory Brain Tumor
- Neuroblastoma. CNS
- Glioblastoma, IDH-mutant
- Glioblastoma, IDH-wildtype
- Medulloblastoma, Group 3
- Medulloblastoma, Group 4
- Glioma, High Grade
- Neuroepithelial Tumor, High Grade
- Medulloblastoma, SHH-activated and TP53 Mutant
- Medulloblastoma, SHH-activated and TP53 Wildtype
- Medulloblastoma, Chromosome 9q Loss
- Medulloblastoma, Non-WNT Non-SHH, NOS
- Medulloblastoma, Non-WNT/Non-SHH
- Medulloblastoma, PTCH1 Mutation
- Medulloblastoma, WNT-activated
- Ependymoma, Recurrent
- Glioma, Recurrent High Grade
- Glioma, Recurrent Malignant
- Embryonal Tumor, NOS
- Glioma, Diffuse Midline, H3K27M-mutant
- Embryonal Tumor With Multilayered Rosettes (ETMR)
- Ependymoma, NOS, WHO Grade III
- Ependymoma, NOS, WHO Grade II
- Medulloblastoma, G3/G4
- Ependymoma, RELA Fusion Positive

## Interventions

- **DRUG:** Gemcitabine
- **DRUG:** ribociclib
- **DRUG:** sonidegib
- **DRUG:** trametinib
- **BIOLOGICAL:** filgrastim

## Key facts

- **NCT ID:** NCT03434262
- **Lead sponsor:** St. Jude Children's Research Hospital
- **Sponsor class:** OTHER
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-03-05
- **Primary completion:** 2022-09-30
- **Final completion:** 2024-05-24
- **Target enrollment:** 68 (ACTUAL)
- **Last updated:** 2024-05-31

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03434262

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03434262, "SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors". Retrieved via AI Analytics 2026-05-30 from https://api.ai-analytics.org/clinical/NCT03434262. Licensed CC0.

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