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

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.

Conditions

High Grade Glioma, CNS Tumor

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
High Grade Glioma
Intervention / Treatment

-

Contacts and Locations

Memphis

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

to 3 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

St. Jude Children's Research Hospital,

Daniel Moreira, MD, MEd, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

2032-11