Infant-Type Hemispheric GliomaPhase 2NCT07916389
Molecularly Stratified Trial for Newly Diagnosed Infant-Type Hemispheric Glioma
A Phase 2 study testing Alectinib, Entrectinib and Surgery in people with Infant-Type Hemispheric Glioma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 60 months
- Conditions the study is for
- Infant-Type Hemispheric Glioma
- What is being tested?
- Alectinib, Entrectinib and Surgery
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2036
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
- Age > 60 months
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Tabatha E. Doyle, RN, 901-595-2544, tabatha.doyle@stjude.org
Aditi Bagchi, M.D., Ph.D.
About this study
Official title: A Molecularly Stratified Phase II Trial for Newly Diagnosed Infant-Type Hemispheric Glioma (IHG)
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.
Read the detailed description
Primary Objective
- To estimate the complete tumor response rate (CTR) associated with molecularly directed neoadjuvant treatment (entrectinib for NTRK1/2/3 and ROS1, alectinib for ALK, and chemotherapy for tumors with other fusions and no fusions). (Strata A, B, and C)
- To estimate the safe surgical resection rate associated with molecular-directed neo-adjuvant treatment entrectinib for NTRK1/2/3 and ROS1, alectinib for ALK, and chemotherapy for tumors with other fusions and no fusions. (Strata A, B, and C)
Secondary Objectives
- To estimate the stratum-specific and study-wide event-free survival (EFS) and overall survival (OS) for patients enrolled in SJIHG25 (Strata A, B, C, and D)
- To estimate the change in neurodevelopment and cognitive performance pre- and post-primary surgery in infants with newly diagnosed IHG treated with molecularly directed neoadjuvant treatment. (Strata A, B, and C)
This is a phase II clinical trial evaluating the use of molecularly directed neoadjuvant treatment for patients with newly diagnosed Infant-Type Hemispheric Glioma (IHG) to improve surgical outcome (efficacy and safety).
Bridge Therapy is recommended for participants who are being screened (participants who have signed the screening consent) for the following reasons:
- Participant can be enrolled on the stratum bridge and 1-4 courses of cytotoxic chemotherapy CCE (carboplatin IV day 2, cyclophosphamide IV day1, and etoposide IV days 1 and 2), which may be given prior to surgical intervention to stabilize the patient. Each cycle of CCE treatment cycle is approximately 28 days in length.
- If the waiting period for diagnostic work-up is deemed unsafe for clinical reasons, the participant may enroll in the stratum bridge and receive one course of bridge chemotherapy with CCE before enrollment to stratum A, B, or C.
- Where a molecular target has been identified prior to screening and confirmation of diagnosis by central pathology review, the participant can be enrolled on stratum bridge and started on treatment based on the molecular target (alectinib po day1-28, entrectinib po day1-28, or chemotherapy (CCE), with pending central pathology review, if waiting for completion of the central pathology review is deemed to put the patient at increased risk of tumor progression.
Decisions regarding bridge therapy need to be discussed and approved by the study PI/team before starting treatment.
Enrollment in strata A, B, C, and D can occur only after central pathology review at St. Jude Children's Research Hospital confirms the diagnosis. Participants will be assigned to treatment strata based on whether residual tumor is present and types of RTK fusion.
Participants with ALK fusion will receive alectinib as neoadjuvant treatment (Stratum A), participants with NTRK 1/2/3 or ROS1 fusions will receive entrectinib as neoadjuvant treatment (Stratum B), and participants with no RTK fusion or RTK fusions other than ALK, ROS1 or NTRK1/2/3 (including MET fusion) will receive chemotherapy with carboplatin, etoposide, and cyclophosphamide as neoadjuvant treatment (Stratum C). Post primary surgery all participants on Strata A, B and C will be treated with 4 courses (1 course = 28 days) of adjuvant chemotherapy with carboplatin, etoposide, and cyclophosphamide.
The participants who have no residual disease at the time of enrollment will be treated with 4 courses (1 course = 28 days) of adjuvant chemotherapy with carboplatin, etoposide, and cyclophosphamide on stratum D.
Participants will be followed for five years following enrollment.
- Conditions
- Infant-Type Hemispheric Glioma
- Being tested
- Alectinib, Entrectinib, Surgery, Cyclophosphamide, Etoposide
- Keywords
- Brain Tumor, Infant-Type Hemispheric Glioma, Newly Diagnosed, Molecularly Stratified, Gene fusions involving ALK, Gene fusions involving NTRK1/2/3, Gene fusions involving ROS1, In-frame MET gene fusion or any other in frame fusion, Measurable primary residual tumor, No measurable primary residual tumor, Supra-tentorial, hemispheric tumor, Neoadjuvant treatment, Surgery, Adjuvant treatment
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlectinibDrug
Also called RO5424802
By mouth, nasogastric, or gastronomy/stomach tube, Day 1-28
EntrectinibDrug
Also called RO7102122
By mouth, nasogastric, or gastronomy/stomach tube, Day 1-28
SurgeryProcedure or surgery
Also called Surgical Resection
Primary surgery (Strata A, B, and C) post Neoadjuvant therapy with a goal of attaining gross total (GTR) or near total resection (NTR) of the tumor.
CyclophosphamideDrug
Also called Cytoxan
IV (intravenous) day 1
EtoposideDrug
Also called VP-16
IV (intravenous) days 1 and 2
CarboplatinDrug
Also called Paraplatin
IV (intravenous) day 2
FilgrastimBiological
Also called G-CSF
Subcutaneous (under the skin) or IV (intravenous) day 3
PegfilgrastimBiological
Also called Neulasta
Subcutaneous (under the skin) day 3
SurgeryProcedure or surgery
Also called Surgical Resection
Primary surgery (Strata A, B, and C) post Neoadjuvant therapy with a goal of attaining gross total (GTR) or near total resection (NTR) of the tumor.
| Study group | Role | What they receive |
|---|---|---|
| Stratum A | Experimental | * Neoadjuvant Treatment: Participants with ALK fusions will receive neoadjuvant treatment (4 Courses) with alectinib.
* Surgery
* Adjuvant Therapy: Participants will receive adjuvant chemotherapy with carboplatin, etoposide, and cyclophosphamide (4 courses). Receives: Drug: Alectinib; Procedure: Surgery; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Carboplatin; Biological: Filgrastim; Biological: Pegfilgrastim |
| Stratum B | Experimental | * Neoadjuvant Treatment: Participants with NTRK 1/2/3 or ROS1 fusions will receive neoadjuvant (4 Courses) treatment with entrectinib.
* Surgery
* Adjuvant Therapy: Participants will receive adjuvant chemotherapy with carboplatin, etoposide, and cyclophosphamide (4 courses). Receives: Drug: Entrectinib; Procedure: Surgery; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Carboplatin; Biological: Filgrastim; Biological: Pegfilgrastim |
| Stratum C | Experimental | * Neoadjuvant Treatment: Participants no RTK fusion or RTK fusions other than ALK, ROS1 or NTRK1/2/3 (including MET fusion) will receive neoadjuvant chemotherapy with carboplatin, etoposide, and cyclophosphamide (4 courses).
* Surgery
* Adjuvant Therapy: Participants will receive adjuvant chemotherapy with carboplatin, etoposide, and cyclophosphamide (4 courses). Receives: Drug: Cyclophosphamide; Drug: Etoposide; Drug: Carboplatin; Biological: Pegfilgrastim; Procedure: Surgery |
| Stratum D | Experimental | Participants who have no measurable residual disease at the time of enrollment.
* Adjuvant Therapy: Participants will receive adjuvant chemotherapy with carboplatin, etoposide, and cyclophosphamide (4 courses). Receives: Drug: Cyclophosphamide; Drug: Etoposide; Drug: Carboplatin; Biological: Filgrastim; Biological: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Complete Tumor Response (CTR) among patients in Strata A, B, and C
The proportion of patients whose extent of tumor resection meets criteria for gross total / near total resection (GTR/NTR) after neoadjuvant therapy and surgery.
Measured: approximately 4 months after enrollment
Rate of safe surgical resection among patients in Strata A, B, and C
Proportion of patients whose surgery is completed without clinically significant intra-operative blood loss/hemorrhage. Success for this outcome measure will include surgery without any of the following:
(i) Initiation of massive transfusion protocol- i.e., requiring more than one volume (80ml/Kg) of transfusion over a period of 24 hours
(ii) Hemorrhage leading to cessation of surgery
(iii) Hemorrhagic complications leading to second neurosurgery within 72 hours of the first surgery.
Measured: Up to 72 hours after surgery
Secondary outcomes (4)
Event free survival (EFS)
EFS is defined as time from enrollment for treatment (including bridge therapy) until progression, subsequent malignancy or death for any reason or until last follow-up, whichever is earlier.
Measured: 2 years
Overall survival (OS)
OS is defined as time from enrollment for treatment (including bridge therapy) until death for any reason or until last follow-up, whichever is earlier.
Measured: 2 years
Change in neurodevelopment and cognitive performance pre- and post-primary surgery in infants with newly diagnosed IHG treated with molecularly directed neoadjuvant treatment: BSID-4
Measured: Pre-surgery/baseline and after the intervention/procedure/primary surgery for up to 12 weeks
Change in neurodevelopment and cognitive performance pre- and post-primary surgery in infants with newly diagnosed IHG treated with molecularly directed neoadjuvant treatment: NIH Baby Toolbox
Measured: Pre-surgery/baseline and after the intervention/procedure/primary surgery for up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2034 (estimated)
- Study completionNov 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant-Type Hemispheric GliomaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open label neoadjuvant treatment, followed by primary surgery, followed by adjuvant therapy in 3 strata (strata A, B, C) with residual tumor and adjuvant therapy only in patients with no residual tumor (stratum D)
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Baldrick's Foundation, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Aditi Bagchi, M.D., Ph.D., Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916389
- Sponsor's protocol ID
- SJIHG25
- Other IDs
- NCI-2026-07231
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Molecularly Stratified Phase II Trial for Newly Diagnosed Infant-Type Hemispheric Glioma (IHG)
- ClinicalTrials.gov ID
- NCT07916389
- Acronym / sponsor ID
- SJIHG25
- Conditions
- Infant-Type Hemispheric Glioma
- Keywords
- Brain Tumor, Infant-Type Hemispheric Glioma, Newly Diagnosed, Molecularly Stratified, Gene fusions involving ALK, Gene fusions involving NTRK1/2/3, Gene fusions involving ROS1, In-frame MET gene fusion or any other in frame fusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- St. Baldrick's Foundation, Genentech, Inc.
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2034 (estimated)
- Study completion
- Nov 2036 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective
- To estimate the complete tumor response rate (CTR) associated with molecularly directed neoadjuvant treatment (entrectinib for NTRK1/2/3 and ROS1, alectinib for ALK, and chemotherapy for tumors with other fusions and no fusions). (Strata A, B, and C)
- To estimate the safe surgical resection rate associated with molecular-directed neo-adjuvant treatment entrectinib for NTRK1/2/3 and ROS1, alectinib for ALK, and chemotherapy for tumors with other fusions and no fusions. (Strata A, B, and C)
Secondary Objectives
- To estimate the stratum-specific and study-wide event-free survival (EFS) and overall survival (OS) for patients enrolled in SJIHG25 (Strata A, B, C, and D)
- To estimate the change in neurodevelopment and cognitive performance pre- and post-primary surgery in infants with newly diagnosed IHG treated with molecularly directed neoadjuvant treatment. (Strata A, B, and C)
This is a phase II clinical trial evaluating the use of molecularly directed neoadjuvant treatment for patients with newly diagnosed Infant-Type Hemispheric Glioma (IHG) to improve surgical outcome (efficacy and safety).
Bridge Therapy is recommended for participants who are being screened (participants who have signed the screening consent) for the following reasons:
- Participant can be enrolled on the stratum bridge and 1-4 courses of cytotoxic chemotherapy CCE (carboplatin IV day 2, cyclophosphamide IV day1, and etoposide IV days 1 and 2), which may be given prior to surgical intervention to stabilize the patient. Each cycle of CCE treatment cycle is approximately 28 days in length.
- If the waiting period for diagnostic work-up is deemed unsafe for clinical reasons, the participant may enroll in the stratum bridge and receive one course of bridge chemotherapy with CCE before enrollment to stratum A, B, or C.
- Where a molecular target has been identified prior to screening and confirmation of diagnosis by central pathology review, the participant can be enrolled on stratum bridge and started on treatment based on the molecular target (alectinib po day1-28, entrectinib po day1-28, or chemotherapy (CCE), with pending central pathology review, if waiting for completion of the central pathology review is deemed to put the patient at increased risk of tumor progression.
Decisions regarding bridge therapy need to be discussed and approved by the study PI/team before starting treatment.
Enrollment in strata A, B, C, and D can occur only after central pathology review at St. Jude Children's Research Hospital confirms the diagnosis. Participants will be assigned to treatment strata based on whether residual tumor is present and types of RTK fusion.
Participants with ALK fusion will receive alectinib as neoadjuvant treatment (Stratum A), participants with NTRK 1/2/3 or ROS1 fusions will receive entrectinib as neoadjuvant treatment (Stratum B), and participants with no RTK fusion or RTK fusions other than ALK, ROS1 or NTRK1/2/3 (including MET fusion) will receive chemotherapy with carboplatin, etoposide, and cyclophosphamide as neoadjuvant treatment (Stratum C). Post primary surgery all participants on Strata A, B and C will be treated with 4 courses (1 course = 28 days) of adjuvant chemotherapy with carboplatin, etoposide, and cyclophosphamide.
The participants who have no residual disease at the time of enrollment will be treated with 4 courses (1 course = 28 days) of adjuvant chemotherapy with carboplatin, etoposide, and cyclophosphamide on stratum D.
Participants will be followed for five years following enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Open label neoadjuvant treatment, followed by primary surgery, followed by adjuvant therapy in 3 strata (strata A, B, C) with residual tumor and adjuvant therapy only in patients with no residual tumor (stratum D)
| Arm | Type | Receives |
|---|---|---|
| Stratum A | Experimental | Drug: Alectinib, Procedure: Surgery, Drug: Cyclophosphamide, Drug: Etoposide, Drug: Carboplatin, Biological: Filgrastim, Biological: Pegfilgrastim* Neoadjuvant Treatment: Participants with ALK fusions will receive neoadjuvant treatment (4 Courses) with alectinib. * Surgery * Adjuvant Therapy: Participants will receive adjuvant chemotherapy with carboplatin, etoposide, and cyclophosphamide (4 courses). |
| Stratum B | Experimental | Drug: Entrectinib, Procedure: Surgery, Drug: Cyclophosphamide, Drug: Etoposide, Drug: Carboplatin, Biological: Filgrastim, Biological: Pegfilgrastim* Neoadjuvant Treatment: Participants with NTRK 1/2/3 or ROS1 fusions will receive neoadjuvant (4 Courses) treatment with entrectinib. * Surgery * Adjuvant Therapy: Participants will receive adjuvant chemotherapy with carboplatin, etoposide, and cyclophosphamide (4 courses). |
| Stratum C | Experimental | Drug: Cyclophosphamide, Drug: Etoposide, Drug: Carboplatin, Biological: Pegfilgrastim, Procedure: Surgery* Neoadjuvant Treatment: Participants no RTK fusion or RTK fusions other than ALK, ROS1 or NTRK1/2/3 (including MET fusion) will receive neoadjuvant chemotherapy with carboplatin, etoposide, and cyclophosphamide (4 courses). * Surgery * Adjuvant Therapy: Participants will receive adjuvant chemotherapy with carboplatin, etoposide, and cyclophosphamide (4 courses). |
| Stratum D | Experimental | Drug: Cyclophosphamide, Drug: Etoposide, Drug: Carboplatin, Biological: Filgrastim, Biological: PegfilgrastimParticipants who have no measurable residual disease at the time of enrollment. * Adjuvant Therapy: Participants will receive adjuvant chemotherapy with carboplatin, etoposide, and cyclophosphamide (4 courses). |
Who may qualify
- Ages
- Up to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (3 listed)
- Age > 60 months
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlectinibAlso: RO5424802By mouth, nasogastric, or gastronomy/stomach tube, Day 1-28 | Drug | Stratum A |
| EntrectinibAlso: RO7102122By mouth, nasogastric, or gastronomy/stomach tube, Day 1-28 | Drug | Stratum B |
| SurgeryAlso: Surgical ResectionPrimary surgery (Strata A, B, and C) post Neoadjuvant therapy with a goal of attaining gross total (GTR) or near total resection (NTR) of the tumor. | Procedure or surgery | Stratum A, Stratum B |
| CyclophosphamideAlso: CytoxanIV (intravenous) day 1 | Drug | Stratum A, Stratum B, Stratum C, Stratum D |
| EtoposideAlso: VP-16IV (intravenous) days 1 and 2 | Drug | Stratum A, Stratum B, Stratum C, Stratum D |
| CarboplatinAlso: ParaplatinIV (intravenous) day 2 | Drug | Stratum A, Stratum B, Stratum C, Stratum D |
| FilgrastimAlso: G-CSFSubcutaneous (under the skin) or IV (intravenous) day 3 | Biological | Stratum A, Stratum B, Stratum D |
| PegfilgrastimAlso: NeulastaSubcutaneous (under the skin) day 3 | Biological | Stratum A, Stratum B, Stratum C, Stratum D |
| SurgeryAlso: Surgical ResectionPrimary surgery (Strata A, B, and C) post Neoadjuvant therapy with a goal of attaining gross total (GTR) or near total resection (NTR) of the tumor. | Procedure or surgery | Stratum C |
Primary outcome
Rate of Complete Tumor Response (CTR) among patients in Strata A, B, and C
Time frame: approximately 4 months after enrollment
The proportion of patients whose extent of tumor resection meets criteria for gross total / near total resection (GTR/NTR) after neoadjuvant therapy and surgery.
Rate of safe surgical resection among patients in Strata A, B, and C
Time frame: Up to 72 hours after surgery
Proportion of patients whose surgery is completed without clinically significant intra-operative blood loss/hemorrhage. Success for this outcome measure will include surgery without any of the following: (i) Initiation of massive transfusion protocol- i.e., requiring more than one volume (80ml/Kg) of transfusion over a period of 24 hours (ii) Hemorrhage leading to cessation of surgery (iii) Hemorrhagic complications leading to second neurosurgery within 72 hours of the first surgery.
4 secondary outcomes
Event free survival (EFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Change in neurodevelopment and cognitive performance pre- and post-primary surgery in infants with newly diagnosed IHG treated with molecularly directed neoadjuvant treatment: BSID-4
Time frame: Pre-surgery/baseline and after the intervention/procedure/primary surgery for up to 12 weeks
Change in neurodevelopment and cognitive performance pre- and post-primary surgery in infants with newly diagnosed IHG treated with molecularly directed neoadjuvant treatment: NIH Baby Toolbox
Time frame: Pre-surgery/baseline and after the intervention/procedure/primary surgery for up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- St. Jude Brain Tumor StudiesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aditi Bagchi, M.D., Ph.D. principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alectinib, Entrectinib and Surgery in people with Infant-Type Hemispheric Glioma, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tabatha E. Doyle, RN (901-595-2544, tabatha.doyle@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Complete Tumor Response (CTR) among patients in Strata A, B, and C (time frame: approximately 4 months after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.