Molecularly Stratified Trial for Newly Diagnosed Infant-Type Hemispheric Glioma

Más betegség

• Any prior cancer-directed therapy
• Organ Dysfunction, or a medical condition that, in the principal investigator's judgment, could compromise their ability to tolerate or absorb protocol therapy or would interfere with study procedures and results.

Életkor

• Age > 60 months

• Patient with presumptive or suspected (new) diagnosis of Infant-Type Hemispheric Glioma (IHG)
• Patient age at diagnosis is from birth to ≤ 60 months
• Patient has MRI/CT scan imaging of a supra-tentorial, hemispheric tumor avail-able for review before screening consent.
• Patient is willing to undergo a biopsy procedure to confirm tissue diagnosis.
• Adequate tumor tissue for central review of pathology, at the St. Jude Children's Research Hospital, DNA methylation array analysis, and NGS testing should be provided, if available from previous surgery, but is not required for screening eligibility.
• The parent or legal guardian of the patient should be able to understand and be willing to sign a written informed consent document according to institutional guidelines
• Without a central pathology confirmed diagnosis of IHG
  • Stratum-Bridge
  • The patient should meet all screening criteria and should have signed the screening consent.
  • Meets one of the exception/modification criteria
• Centrally confirmed diagnosis of IHG
  • Strata A and B
  • The tumor has confirmed in-frame gene fusions involving ALK (Stratum A)
  • The tumor has confirmed in-frame gene fusions involving NTRK1/2/3 or ROS1 (Stratum B).
  • A measurable primary residual tumor at the time of enrollment
  • Stratum C
  • Central pathology review doesn't detect in-frame gene fusion involving ALK, NTRK 1/2/3, or ROS1in the tumor
  • Central pathology review confirms the presence of in-frame MET gene fusion or any other in frame fusion other than those involving ALK, NTRK1/2/3, or ROS1 gene fusions
  • A measurable primary residual tumor at the time of enrollment
  • Stratum D
  • No measurable primary residual tumor at the time of enrollment