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Liothyronine with BIT Regimen for Medulloblastoma

This study is testing a new approach for children and young adults (ages 1 to 25) with medulloblastoma, a type of brain tumor, that has come back or gotten worse after standard treatments. It's looking at a drug called liothyronine (L-T3), which works by affecting the immune system (immunotherapy). Liothyronine will be given by itself or in combination with standard chemotherapy drugs: bevacizumab, irinotecan, and temozolomide (BIT regimen). The main goals are to find out how safe these treatments are, what the highest safe dose is, and if they cause any serious side effects. This study aims to enroll 69 participants. The current status of this study is unclear.

Study design
This is an interventional study with two parts (Phase 1 and Phase 2). It involves a dose escalation phase and will enroll 69 participants.
What's involved
Participants may continue therapy for up to 12 cycles, and potentially for an additional year of liothyronine monotherapy (24 cycles total), if they are benefiting and not experiencing unacceptable side effects.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed after the 30-day toxicity period. The primary endpoints for safety are measured up to 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07346157

Liothyronine in Combination With BIT Regimen for Medulloblastoma With or Without Minimal Residual Disease

Recruiting
PHASE1Ages 1–25InterventionalTreatment
Sabine Mueller, MD, PhD
~69 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Liothyronine (L-T3)BevacizumabIrinotecanTemozolomide (TMZ)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants experienced an Adverse Event
Measured over Up to 28 days
+4 more outcomes measured

Conditions

Medulloblastoma
Medulloblastoma, Childhood
Medulloblastoma Recurrent

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NCT07346157

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's National Hospital

    Washington D.C., District of Columbiastudy coordinator listed

    Recruiting

  • University of California, San Francisco

    San Francisco, Californiastudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sabine Mueller · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Kelly Hitchner
[email protected]
877-827-3222
Email the study team

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Eligibility criteria

Inclusion

Alanine aminotransferase (ALT) ≤ 5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) ≤ 5 x ULN. 3.3.7.4 Adequate Neurologic Function Defined as:
Participants with seizure disorder may be enrolled if well controlled. Participants on non-enzyme inducing anticonvulsants may be excluded pending interaction(s) with study drug. 3.3.7.5 Adequate Cardiac Function Defined as:
Normal left ventricular systolic function on baseline transthoracic echocardiogram (TTE)
Normal left ventricular systolic function is defined as left ventricular ejection fraction (LVEF) \>55% or shortening fraction (SF) \>28%.
No clinically significant arrhythmia on baseline ECG (sinus arrhythmia, sinus tachycardia, sinus bradycardia, early repolarization and 1st degree atrioventricular block when partial response (PR) interval \< 300 millisecond (ms) are not considered clinically significant arrhythmias).
In addition, the following ECG findings are not considered clinically significant in the setting of a normal echocardiogram:
Left axis deviation
Left atrial enlargement
Right atrial enlargement
Possible left ventricular hypertrophy
Possible right ventricular hypertrophy
Non-specific T wave abnormality 3.3.7.6 For the Phase 1 cohort, normal adrenal axis function is required. For those participants in the Phase 2 cohort, must have controlled adrenal insufficiency \>3 months (no change in steroid replacement or stress dose plan for at least 3 months).
Normal adrenal axis function as defined as:
Morning (AM) cortisol \>11mcg/deciliter (dL)
If AM cortisol is \<11 microgram (mcg)/dL, cosyntropin stimulation test with rise to \>18 9. Endocrine conditions: Participants with diabetes insipidus, diabetes melitus, or being treated with levothyroxine, must have stable dosing and control for minimum of 3 months prior to enrollment 10. For Cohort 1 only: participants must have recovered from any surgical procedure before enrolling on this study (see below for examples of major, intermediate, and minor surgical procedures):

What this trial measures

  • Proportion of participants experienced an Adverse EventUp to 28 days

    Proportion of participants with adverse events of L-T3 as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0)

  • Proportion of participants who experience dose-limiting toxicity (DLT) (Dose Escalation)Up to 28 days

    The DLT evaluable analysis set includes all participants in the dose-finding part of the study who have received the target doses of L-T3, and who have either experienced a DLT or were followed for the full DLT evaluation period. DLT is defined as L-T3-related toxicity at a frequency ≥33% in any treatment arm.

  • Maximum Tolerated Dose (MTD) (Dose Escalation)Up to 28 days

    The DLT evaluable analysis set includes all participants in the dose-finding part of the study who have received the target doses of L-T3, and who have either experienced a DLT or were followed for the full DLT evaluation period. The MTD is defined as the dose level given for 14 days which ≤ 1/6 participants experience a DLT.

  • Percentage Progressive Free Survival (PFS) at month 9up to 9 months

    Cohort 1 Phase 2, PFS at 9 months is defined as the proportion of patients alive and progression-free 9 months from start of treatment. Any patient lost-to-follow-up prior to 9 months will be considered an event (i.e., progression/death) for the purposes of the analysis.

  • Percentage of cf-DNA clearanceUp to 30 days after last dose of L-T3.

    Participants in Cohort 2 Phase 2 will be assessed in two serial measurements of at least one month apart to determine cf-DNA clearance in cerebrospinal fluid (CSF). Percentage of participants with cf-DNA clearance will be reported.