NCT07916389Not yet recruitingPhase 2
Molecularly Stratified Trial for Newly Diagnosed Infant-Type Hemispheric Glioma
A Molecularly Stratified Phase II Trial for Newly Diagnosed Infant-Type Hemispheric Glioma (IHG)
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to test whether giving treatment before surgery helps babies who are newly diagnosed with Infant-Type Hemispheric Glioma (IHG) have safer and better surgery results.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 13 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Nov 2034
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT07916389
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From Nov 2026 to the primary completion date, Nov 2034
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Age
- Age > 60 months
Who the study is looking for
- 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
Age in the registry: - to 60 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.