RECRUITING

Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors

Conditions

High Grade Glioma CNS Tumor CNS Tumors High Grade Glioma with NTRK1/2/3 gene fusion High Grade Glioma with ROS1 gene fusion CNS tumor other than HGG harboring NTRK1/2/3 gene fusion CNS tumor other than HGG harboring ROS1 gene fusion Children

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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 clinical trial tests how well entrectinib works to treat patients less than 3 years of age with NTRK 1/2/3 or ROS1 fused, high grade glioma or other central nervous system (CNS) tumors.

Official Title

PHASE 2 Study of Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors (GLOBOTRK)

Quick Facts

Study Start:2024-12

Study Completion:2032-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06528691

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:Not specified to 3 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Age from birth to age \<3 years at the time of diagnosis (date of surgical resection/biopsy) * Participant with presumed newly diagnosed tumor in the supratentorial compartment * Patient must have measurable disease based on RAPNO criteria * ≤42 days since surgery (resection or biopsy) * Available tumor tissue for central review * Parent/guardian has the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines	* Previous exposure to cytotoxic chemotherapy or radiotherapy

Inclusion Criteria

Exclusion Criteria

* Age from birth to age \<3 years at the time of diagnosis (date of surgical resection/biopsy)
* Participant with presumed newly diagnosed tumor in the supratentorial compartment
* Patient must have measurable disease based on RAPNO criteria
* ≤42 days since surgery (resection or biopsy)
* Available tumor tissue for central review
* Parent/guardian has the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines

* Previous exposure to cytotoxic chemotherapy or radiotherapy

Contacts and Locations

Study Contact

Daniel Moreira, MD, MEd

CONTACT

866-278-5833

referralinfo@stjude.org

Principal Investigator

Daniel Moreira, MD, MEd

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

Daniel Moreira, MD, MEd, 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 Date2024-12

Study Completion Date2032-11

Study Record Updates

Study Start Date2024-12

Study Completion Date2032-11

Terms related to this study

Keywords Provided by Researchers

CNS Tumors
High Grade Glioma with NTRK1/2/3 gene fusion
High Grade Glioma with ROS1 gene fusion
CNS tumor other than HGG harboring NTRK1/2/3 gene fusion
CNS tumor other than HGG harboring ROS1 gene fusion
Children

Additional Relevant MeSH Terms

High Grade Glioma
CNS Tumor