Molecularly Stratified Trial for Newly Diagnosed Infant-Type Hemispheric Glioma

October 29, 2026 updated by: St. Jude Children's Research Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital
        • Contact:
        • Principal Investigator:
          • Aditi Bagchi, M.D., Ph.D.

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Screening

  • 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

Inclusion Criteria: Enrollment

  • 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

Exclusion Criteria: (All Strata)

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stratum A
  • 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).
Drug: Alectinib

By mouth, nasogastric, or gastronomy/stomach tube, Day 1-28

Other Names:
  • RO5424802
Procedure: Surgery

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.

Other Names:
  • Surgical Resection
Drug: Cyclophosphamide

IV (intravenous) day 1

Other Names:
  • Cytoxan
Drug: Etoposide

IV (intravenous) days 1 and 2

Other Names:
  • VP-16
Drug: Carboplatin

IV (intravenous) day 2

Other Names:
  • Paraplatin
Biological: Filgrastim

Subcutaneous (under the skin) or IV (intravenous) day 3

Other Names:
  • G-CSF
Biological: Pegfilgrastim

Subcutaneous (under the skin) day 3

Other Names:
  • Neulasta
Experimental: Stratum B
  • 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).
Procedure: Surgery

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.

Other Names:
  • Surgical Resection
Drug: Cyclophosphamide

IV (intravenous) day 1

Other Names:
  • Cytoxan
Drug: Etoposide

IV (intravenous) days 1 and 2

Other Names:
  • VP-16
Drug: Carboplatin

IV (intravenous) day 2

Other Names:
  • Paraplatin
Biological: Filgrastim

Subcutaneous (under the skin) or IV (intravenous) day 3

Other Names:
  • G-CSF
Biological: Pegfilgrastim

Subcutaneous (under the skin) day 3

Other Names:
  • Neulasta
Drug: Entrectinib

By mouth, nasogastric, or gastronomy/stomach tube, Day 1-28

Other Names:
  • RO7102122
Experimental: Stratum C
  • 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).
Procedure: Surgery

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.

Other Names:
  • Surgical Resection
Drug: Cyclophosphamide

IV (intravenous) day 1

Other Names:
  • Cytoxan
Drug: Etoposide

IV (intravenous) days 1 and 2

Other Names:
  • VP-16
Drug: Carboplatin

IV (intravenous) day 2

Other Names:
  • Paraplatin
Biological: Pegfilgrastim

Subcutaneous (under the skin) day 3

Other Names:
  • Neulasta
Experimental: Stratum D

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).
Drug: Cyclophosphamide

IV (intravenous) day 1

Other Names:
  • Cytoxan
Drug: Etoposide

IV (intravenous) days 1 and 2

Other Names:
  • VP-16
Drug: Carboplatin

IV (intravenous) day 2

Other Names:
  • Paraplatin
Biological: Filgrastim

Subcutaneous (under the skin) or IV (intravenous) day 3

Other Names:
  • G-CSF
Biological: Pegfilgrastim

Subcutaneous (under the skin) day 3

Other Names:
  • Neulasta

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
approximately 4 months after enrollment
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.
Up to 72 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Event free survival (EFS)
Time Frame: 2 years

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.
2 years
Overall survival (OS)
Time Frame: 2 years

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.
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
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
Pre-surgery/baseline and after the intervention/procedure/primary surgery for up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Jude Children's Research Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Genentech, Inc.
St. Baldrick's Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aditi Bagchi, M.D., Ph.D., St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2034

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJIHG25
  • NCI-2026-07231 (Registry Identifier: NCI Clinical Trial Registration Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be made available at the time of article publication.

IPD Sharing Access Criteria

Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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