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Newly Diagnosed
ACNS1831: A Phase 3 Randomized Study of Selumetinib (IND #77782) Versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG) Diagnosis: Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)
ACNS1833: A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1) Diagnosis: Low-Grade Glioma (LGG)
Relapsed / Refractory
PBTC-055: Phase I/II Trial of Dabrafenib, Trametinib, and Hydroxychloroquine (HCQ) for BRAF V600E-Mutant or Trametinib and HCQ for BRAF Fusion/Duplication Positive or NF1-Associated Recurrent or Progressive Gliomas in Children and Young Adults Diagnosis: LGG/HGG & LGG with NF1
ACNS1931: A Phase 3 Study of Selumetinib (NSC# 748727) or Selumetinib in Combination With Vinblastine for Non-NF1, Non-TSC Patients With Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations Diagnosis: LGG lacking BRAFV600E or IDH1 Mutations
PBTC060: A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma Diagnosis: Diffuse Intrinsic Pontine Glioma (DIPG)
PBTC048: Optune for Children With High-Grade Glioma or Ependymoma, and Optune With Radiation Therapy for Children With DIPG Diagnosis: Diffuse Intrinsic Pontine Glioma (DIPG)
GD2 CAR-T: Phase 1 Clinical Trial of Autologous GD2 Chimeric Antigen Receptor (CAR) T cells (GD2CART) for Diffuse Intrinsic Pontine Gliomas (DIPG) and Spinal Diffuse Midline Glioma (DMG) Diagnosis: Diffuse Intrinsic Pontine Glioma (DIPG) and Spinal Cord Diffuse Midline Glioma (DMG) that is H3K27 mutated
ACNS1821: A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG) Diagnosis: Diffuse Intrinsic Pontine Glioma (DIPG)
PBTC-049: A Phase I Study of Savolitinib in Recurrent, Progressive or Refractory Primary CNS Tumors Diagnosis: Recurrent, progressive, or refractory primary CNS tumor with evidence of genetic activation of the MET pathway
ACNS1723: A Phase 2 Study of Dabrafenib (NSC# 763760) With Trametinib (NSC# 763093) After Local Irradiation in Newly-Diagnosed BRAF V600-Mutant High-Grade Glioma (HGG) Diagnosis: BRAF V600-Mutant HGG
ACNS1821: A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG) Diagnosis: High-Grade Glioma (HGG)
PBTC060: A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma Diagnosis: High Grade Glioma (HGG)
PBTC048: A Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma Diagnosis: Supratentorial HGG
PBTC-045: A Safety and Preliminary Efficacy trial of MK-3475 (pembrolizumab; anti-PD-1) in children with recurrent, progressive or refractory high-grade gliomas (HGG), DIPGs and hypermutated brain tumors Diagnosis: Stratum B- histologically confirmed diagnosis of a non-brainstem high-grade glioma (NB-HGG) that is recurrent, progressive or refractory following therapy which included radiotherapy. Spinal primary disease is eligible
PBTC-055: Phase I/II Trial of Dabrafenib, Trametinib, and Hydroxychloroquine (HCQ) for BRAF V600E-Mutant or Trametinib and HCQ for BRAF Fusion/Duplication Positive or NF1-Associated Recurrent or Progressive Gliomas in Children and Young Adults Diagnosis: Phase 2 stratum 4: HGG with BRAF V600E/D/K mutation
There are currently no trials for Newly Diagnosed Ependymomas.
PBTC060: A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma Diagnosis: Ependymoma
PBTC048: A Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma Diagnosis: Supratentorial ependymoma
SJiMB21: Phase 2 Study of Molecular and Clinical Risk-Directed Therapy for Infants and Young Children with Newly Diagnosed Medulloblastoma Diagnosis: Medulloblastoma
PBTC060: A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma Diagnosis: Medulloblastoma
No current Atypical Teratoid Rhabdoid Tumor trials
PEPN2121: A Phase 1/2 Study of Tiragolumab (NSC# 827799, IND# 161266) and Atezolizumab (NSC# 783608, IND# 161266) in Patients with Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors Diagnosis: Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors
ACNS1831- A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG) Diagnosis: NF1 associated LGG
Relapse / Refractory
PBTC-055: Phase I/II Trial of Dabrafenib, Trametinib, and Hydroxychloroquine (HCQ) for BRAF V600E-Mutant or Trametinib and HCQ for BRAF Fusion/Duplication Positive or NF1-Associated Recurrent or Progressive Gliomas in Children and Young Adults Diagnosis: NF1-associated recurrent or progressive gliomas
Other - nontreatment
NF1-OPG Natural History Study: Developing Evidence-Based Criteria for Initiating Treatment for Neurofibromatosis Type 1 Associated Optic Pathway Glioma/CTF 004: The Collection of Blood Samples from Patients with NF1 for Research Purposes Diagnosis: Optic pathway glioma
NF1 Patient Registry Diagnosis: NF
Other & Molecular Based Therapies
ACNS2021: A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor Diagnosis: Newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region
ACCL2031: A Phase 3 Randomized, Placebo-Controlled Trial Evaluating Memantine (IND# 149832) for Neurocognitive Protection in Children Undergoing Cranial Radiotherapy as Part of Treatment for Primary Central Nervous System Tumors Diagnosis: Primary Central Nervous System Tumors
G042286: A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available Diagnosis: CNS or solid tumors harboring ALK gene fusions
ALTE07C1: Neuropsychological, Social, Emotional and Behavioral Outcomes in Children with Cancer Diagnosis: Non-disease specific, nontreatment
APEC14B1: The Project: Everychild Protocol: A Registry, Eligibility, Screening, Biology, and Outcome Study Diagnosis: Registry or eligibility arm
APEC1621: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Diagnosis: CNS diagnosis with specific mutation
Further Information and Summaries for Health Care Professionals
Pediatric Brain Tumor Consortium
The Children's Oncology Group
To find out the current status of any study please contact us at:
Merkel@stanford.edu
