RECRUITING

SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma

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Conditions

Low-Grade GliomaRecurrent Low-Grade GliomaProgressive Low-Grade GliomaBrain tumors in AdolescentBrain tumors in ChildrenBrain tumors in Young AdultsAstrocytic tumorGlioneuronal tumorNeuroepithelial tumor, not otherwise specified (NOS)Neuroepithelial tumor, not elsewhere classified (NEC)Pilocytic astrocytomaPilomyxoid astrocytomaPleomorphic xanthroastrocytomaGangliogliomaGangliocytomaDiffuse gliomaDiffuse astrocytomaOligodendrogliomaOligoastrocytomaPapillary glioneuronal tumorRosette-forming glioneuronal tumorDiffuse leptomeningeal glioneuronal tumorCentral neurocytomaExtraventricular neurocytomaAngiocentric gliomaDysembryoplastic neuroepithelial tumor (DNET)Septal Dysembryoplastic neuroepithelial tumor (DNET)Myxoid glioneuronal tumorTectal gliomaDesmoplastic infantile astrocytomaDesmoplastic infantile gangliogliomaPolymorphous low-grade neuroepithelial tumor of the youngMultinodular and vacuolating neuronal tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label, multi-center, Phase 1/2 study of the brain-penetrant MEK inhibitor, mirdametinib (PD-0325901), in patients with pediatric low-grade glioma (pLGG).

Official Title

SJ901: Phase 1/2 Evaluation of Single Agent Mirdametinib (PD-0325901), a Brain-Penetrant MEK1/2 Inhibitor, for the Treatment of Children, Adolescents, and Young Adults With Low-Grade Glioma

Quick Facts

Study Start:2021-06-21
Study Completion:2031-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04923126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 24 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants with histologically confirmed or suspected low-grade glioma, including neuronal and mixed neuronal-glial tumors
  2. * Participant must have adequate tumor tissue from primary and/or relapsed tumor for central pathology review
  3. * For Phase 1: Projected to be ≥ 2 years and \< 25 years at the time of study enrollment
  4. * Participant's body surface area (BSA) at time of study enrollment must fall within the range outlined in the protocol for the specific dose level under evaluation:
  5. * Phase 1: Dose Finding/Dose-escalation
  6. * For Phase 1 participant's BSA must fall within the range specified in the protocol for the specific dose level under evaluation.
  7. * Phase 2: All Cohorts:
  8. * For Phase 2 of the study the upper BSA restrictions will be removed.
  9. * Participant and/or guardian can understand and is willing to sign a written informed consent document according to institutional guidelines
  1. * Participants with known current retinal pathology that is consistent with or a precursor for central serous retinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration
  2. * Participants with a known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of mirdametinib (e.g., gastric bypass, lap band, or other gastric procedures)
  3. * Participant with a known history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones)
  4. * Participants with a clinically significant history of chronic interstitial lung disease (such as bronchopulmonary dysplasia, chronic bronchiolitis, obliterative bronchiolitis, chronic aspiration pneumonia, surfactant protein disorder, or other serious chronic pulmonary condition). Participants with a history of asthma, reactive airways disease, or viral pneumonitis are not to be excluded if disease has resolved or is well-controlled.

Contacts and Locations

Study Contact

Tabatha E. Doyle, RN
CONTACT
901-595-2544
tabatha.doyle@stjude.org

Principal Investigator

Giles W. Robinson, MD
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Anna Vinitsky, MD, MS
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Giles W. Robinson, MD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital
  • Anna Vinitsky, MD, MS, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-21
Study Completion Date2031-06

Study Record Updates

Study Start Date2021-06-21
Study Completion Date2031-06

Terms related to this study

Keywords Provided by Researchers

  • Brain tumors in Adolescent
  • Brain tumors in Children
  • Brain tumors in Young Adults
  • Astrocytic tumor
  • Glioneuronal tumor
  • Neuroepithelial tumor, not otherwise specified (NOS)
  • Neuroepithelial tumor, not elsewhere classified (NEC)
  • Pilocytic astrocytoma
  • Pilomyxoid astrocytoma
  • Pleomorphic xanthroastrocytoma
  • Ganglioglioma
  • Gangliocytoma
  • Diffuse glioma
  • Diffuse astrocytoma
  • Oligodendroglioma
  • Oligoastrocytoma
  • Papillary glioneuronal tumor
  • Rosette-forming glioneuronal tumor
  • Diffuse leptomeningeal glioneuronal tumor
  • Central neurocytoma
  • Extraventricular neurocytoma
  • Angiocentric glioma
  • Dysembryoplastic neuroepithelial tumor (DNET)
  • Septal Dysembryoplastic neuroepithelial tumor (DNET)
  • Myxoid glioneuronal tumor
  • Tectal glioma
  • Desmoplastic infantile astrocytoma
  • Desmoplastic infantile ganglioglioma
  • Polymorphous low-grade neuroepithelial tumor of the young
  • Multinodular and vacuolating neuronal tumor

Additional Relevant MeSH Terms

  • Low-Grade Glioma
  • Recurrent Low-Grade Glioma
  • Progressive Low-Grade Glioma