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

Sponsor
Sarah Rumler
Study ID
NCT07331064
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
0 Months - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
Dec 2025
Primary completion
Nov 15, 2030
Completion
May 15, 2031

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gallium Maltolate (GaM) Arm
    single-agent GaM study, single arm.

Primary Outcome Measure

GaM tolerance [ Time Frame: From start of treatment with GaM to 30 days after completion of treatment with GaM ]

Central Contacts

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