Pediatric Clinical Trials

We believe ending cancer will require a weapon as adaptable and multiform as the disease itself.
We Believe

We believe ending cancer will require a weapon as adaptable and multiform as the disease itself.

  • PEDIATRIC TRIALS

    Study:  Developing evidence-based criteria for initiating treatment for neurofibromatosis type I-associated optic pathway glioma
    PI:  David Van Mater, MD, PhD 
    Phase:  N/A (Observational) 
    Category:  Pediatric Neuro-Oncology 
    Purpose:  To understand the natural history of vision in NF1 patients with an optic pathway glioma and to determine predictors of future vision loss or change in tumor size. For detailed information, please view this trial at ClinicalTrials.gov 
    IRB number:  Pro00066558 
    Contact:  For more information, please contact Pediatric Neuro-Oncology at 919-684-2288

    Study:  The collection of blood samples from patients with NF1 for research purposes
    PI:  
    David Van Mater, MD, PhD 
    Phase:  N/A (Biorepository) 
    Category:  Pediatric Neuro-Oncology 
    Purpose:  To augment an existing biobank resource for neurofibromatosis type 1 (NF1) research. For detailed information, please view this trial at ClinicalTrials.gov 
    IRB number:  Pro00068686 
    Contact:  For more information, please contact Pediatric Neuro-Oncology at 919-684-2288

    Study:  A clinical and molecular risk-directed therapy for newly diagnosed medulloblastoma (SJMB12)
    PI:  
    David Ashley, PhD
    Category:  Pediatric Neuro-Oncology 
    Purpose:  The purposes of this study are to find out if patients with low-risk,  wingless + int-1 (WNT) tumors can be treated with a lower dose of radiation to the brain and spine and a lower dose of the chemotherapy drug cyclophosphamide, while still achieving the same survival rate as past St. Jude studies with fewer side effects; to find out if adding targeted chemotherapy after standard chemotherapy will benefit participants with sonic Hedgehog (SHH)-positive tumors; and to find out if adding new chemotherapy agents to the standard chemotherapy will improve the outcome for intermediate and high risk non-WNT, non-SHH tumors. For detailed information, please view this trial at ClinicalTrials.gov at NCT01878617
    IRB number: Pro00047285  
    Contact:  For more information, please contact Pediatric Neuro-Oncology at 919-684-2288

  • Recurrent 

    Study:  PBTC-042: Phase I study of CDK 4-6 inhibitor PD-0332991 in children with recurrent, progressive or refractory central nervous system tumors
    PI:  David Van Mater, MD, PhD
    Phase:  I
    Category:  Pediatric Neuro-Oncology
    Purpose:  For detailed information, please view this trial at ClinicalTrials.gov at NCT02255461
    IRB number:  Pro00054303
    Contact:  For more information, please contact Pediatric Neuro-Oncology at 919-684-2288
     
    Study: Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children
    PI:  Eric Thompson, MD
    Phase: IB
    Category: Pediatric Neuro-Oncology
    Purpose: The purpose of the study is to confirm the safety of the selected dose and potential toxicity of oncolytic poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent WHO grade III or IV malignant glioma. For more information, please visit this trial at ClinicalTrials.gov at  NCT03043391
    IRB number:  Pro00071228
    Contact:  For more information, please contact Pediatric Neuro-Oncology at 919-684-2288
     
    Study: PEP-CMV in Recurrent Medulloblastoma/Malignant Glioma (PRiME)
    PI:  Gary Archer, PhD
    Phase: Not yet enrolling
    Category: Pediatric Neuro-Oncology
    Purpose: The primary goal of this prospective clinical trial is to evaluate the safety of PEP-CMV in patients with recurrent medulloblastoma and malignant glioma. Patients with histologically-proven medulloblastoma or malignant glioma who had received definitive chemo-radiotherapy and subsequently had tumor recurrence/progression may be enrolled any time after recurrence/progression regardless of prior adjuvant therapy. PEP-CMV is a vaccine mixture of 2 peptides comprised in two components (referred to as Component A and Component B). Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. Component B consists of a neutralizing antibody epitope from human CMV glycoprotein B (gB) conjugated to KLH. For more information, please visit this trial at ClinicalTrials.gov at NCT03299309
    Contact:  For more information, please contact Pediatric Neuro-Oncology at 919-684-2288