Gallium Maltolate for the Treatment of Pediatric Patients With Relapsed or Refractory Pediatric High-Grade Glioma and Atypical Teratoid Rhabdoid Tumor

NCT07331064 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IIT-Rumler-GABRIEL
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, we want to find out more about the side effects of an investigational drug for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma, Gallium Maltolate (GaM) and what doses of GaM are safe for people to take. Everyone in this study will receive GaM which is still experimental and is not approved by the U.S. Food and Drug Administration. We do not know all the ways that this drug may affect people. We hope the information from this study will help us develop a better treatment for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma in the future.

Conditions

Atypical Teratoid Rhabdoid Tumors (ATRT); High Grade Gliomas; DIPG; Diffuse Midline Glioma; Diffuse Intrinsic Pontine Gliomas (DIPG)

Keywords

DIPG; HGG; ATRT; DMG; relapse; refractory; progressive; high grade glioma; diffuse midline glioma; diffuse intrinsic pontine glioma; atypical teratoid rhabdoid tumor; brain tumor; pediatric

Outcome Measures

Primary Outcomes (3)

• GaM tolerance

  Using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, identify the tolerance of pediatric patients to a specific dose of oral GaM by grading and attribution to GaM of adverse events.

  From start of treatment with GaM to 30 days after completion of treatment with GaM

• RP2D

  Using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, define the MTD, recommended phase 2 dose (RP2D), safety and toxicity of oral gallium maltolate.

  From start of treatment with GaM to 30 days after completion of treatment with GaM

• GaM PK levels

  Measure serum gallium levels at multiple timepoints to calculate pharmacokinetic parameters in pediatric patients

  From start of treatment with GaM to 6 months from start of treatment with GaM (for participants who complete 6 months of treatment).

Secondary Outcomes (3)

• Disease response

  Every 8 weeks for the first 8 cycles (i.e. prior to cycles 3, 5, 7) and then every 12 weeks until completion of therapy (i.e. prior to cycles 10, 13, 16, etc) with GaM due to disease progression or removal from study.

• Survival

  From start of treatment with GaM to 12 months from completion of treatment with GaM.

• Quality of Life Patient Reported Outcomes

  From start of treatment with GaM to 12 months from completion of treatment with GaM

Study Arms (1)

Gallium Maltolate (GaM) Arm

EXPERIMENTAL

single-agent GaM study, single arm.

Drug: Gallium maltolate

Interventions

Gallium maltolate DRUG

oral small-molecule iron mimetic

Gallium Maltolate (GaM) Arm

Eligibility Criteria

• Age: 0 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Voluntary written consent must be obtained before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• Patients must have a prior histological diagnosis of pediatric high-grade glioma (WHO Grade 3 or 4, including DMG/DIPG) or ATRT (WHO Grade 4) or molecular features of such tumors (per the 6th volume of Central Nervous System Tumors in the 5th edition of the WHO Classification of Tumors).
• Patients are required to have received standard treatment for their tumor type which is considered to include at least:
• b. ATRT: maximum safe resection, radiotherapy (focal or craniospinal), and combination chemotherapy per a nationally-accepted ATRT regimen (such as DFCI-ATRT, COG ACNS0334, or MUV-ATRT).
• Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately.
• Cytotoxic chemotherapy (given systemically or intraventricular/intrathecal) or other anti-cancer agents known to be myelosuppressive ≥21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea).
• Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil count \[ANC\] counts): ≥7 days after the last dose of agent.
• Antibodies: ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade ≤1 (for purposes of this study, bevacizumab is considered an antibody).
• Corticosteroids:
• i. If used to modify immune adverse events related to prior therapy, ≥14 days must have elapsed since last dose of corticosteroid.
• ii. If used for symptom management related to tumor edema or elevated ICP, patient should be on a stable dose of corticosteroid for ≥7 days.
• e. Hematopoietic growth factors: ≥14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥ 7 days for short-acting growth factor.
• f. Autologous stem cell infusion, including boost infusion: ≥42 days g. Cellular therapy: ≥42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer \[NK\] cells, dendritic cells) h. h. Radiation therapy (XRT)/external beam irradiation including protons: ≥14 days after local XRT; ≥30 days after whole brain or craniospinal XRT.
• Patients must have measurable disease that can be assessed for response to treatment as defined by RAPNO for high-grade gliomas (59), RAPNO for DIPG (60), or RAPNO for medulloblastoma and other leptomeningeal seeding tumors (for ATRT) (61) that incorporates MRI assessment and clinical factors. In the absence of measurable disease, pathologic confirmation of recurrent disease is required (i.e., positive cerebrospinal fluid cytology).
• Male or female subjects must be 0-17 years of age.

You may not qualify if:

• Presence of other active malignant disease diagnosed within 12 months.
• Known hypersensitivity to or intolerance to gallium-based medications.
• Concurrent use of cytotoxic chemotherapy is not permitted.
• Unstable or severe concurrent medical conditions such as severe heart disease, renal failure, uncontrolled diabetes mellitus, or severe lung disease.
• History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, or symptomatic pleural effusion.
• Patients who have not completed all standard-of-care treatments including surgical procedures and radiation therapy.
• Inability to tolerate an oral medication.
• Patients who are pregnant or nursing.
• Patients with any condition which, in the investigator's opinion, makes the patient unsuitable for study participation.

Sponsors & Collaborators

• Sarah Rumler: lead

MeSH Terms

Conditions

Recurrence; Glioma; Diffuse Intrinsic Pontine Glioma; Rhabdoid Tumor; Brain Neoplasms

Interventions

gallium maltolate

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Stem Neoplasms; Infratentorial Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Complex and Mixed

Central Study Contacts

Sarah Rumler, DO

CONTACT

414-266-2000; srumler@mcw.edu

MACC Fund Center Clinical Trials Office

CONTACT

MACCcto@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: a modified 3 + 3 design with 1 + 1 dose escalation where both escalation and de-escalation are possible.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 9, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): November 15, 2030
• Study Completion (Estimated): May 15, 2031
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At least annually, or sooner if protocol changes, recruitment details, or amendments change.
• Access Criteria: We will not place any restrictions on data and plan to deposit and publish interim results as soon as they are available. There may be an embargo on these data depending the journal that accepts our paper with our findings,