A Phase 2 interventional study of Alectinib and Entrectinib in Infant-Type Hemispheric Glioma, sponsored by St. Jude Children's Research Hospital. Not yet recruiting at 1 site in United States. Open to participants aged Up to 60 Months. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by St. Jude Children's Research Hospital · Phase 2, Interventional, and Treatment
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.
Primary Objective
Secondary Objectives
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:
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.
2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →St. Jude Children's Research Hospital is the lead sponsor of 440 studies on the registry; 102 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 37 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Screening
Inclusion Criteria: Enrollment
Without a central pathology confirmed diagnosis of IHG
Stratum-Bridge
Centrally confirmed diagnosis of IHG
Strata A and B
Stratum C
Stratum D
Exclusion Criteria: (All Strata)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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 · 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).
Drug: Entrectinib · Procedure: Surgery · Drug: Cyclophosphamide · Drug: Etoposide · Drug: Carboplatin · Biological: Filgrastim · Biological: Pegfilgrastim
* 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).
Drug: Cyclophosphamide · Drug: Etoposide · Drug: Carboplatin · Biological: Pegfilgrastim · Procedure: Surgery
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 · Drug: Etoposide · Drug: Carboplatin · Biological: Filgrastim · Biological: Pegfilgrastim
By mouth, nasogastric, or gastronomy/stomach tube, Day 1-28
Also known as: RO5424802
By mouth, nasogastric, or gastronomy/stomach tube, Day 1-28
Also known as: RO7102122
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.
Also known as: Surgical Resection
IV (intravenous) day 1
Also known as: Cytoxan
IV (intravenous) days 1 and 2
Also known as: VP-16
IV (intravenous) day 2
Also known as: Paraplatin
Subcutaneous (under the skin) or IV (intravenous) day 3
Also known as: G-CSF
Subcutaneous (under the skin) day 3
Also known as: Neulasta
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.
Also known as: Surgical Resection
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.
Time frame: 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.
Time frame: Up to 72 hours after surgery
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.
Time frame: 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.
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
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be made available at the time of article publication.
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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Alectinib · Entrectinib · Filgrastim
St. Jude Children's Research Hospital →