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.
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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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 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).
Presence of other active malignant disease diagnosed within 12 months.
Not appropriately recovered from prior therapy as defined by time frames listed in the inclusion criteria (Section 4.5.2.1).
Known hypersensitivity to or intolerance to gallium-based medications.
Concurrent use of cytotoxic chemotherapy is not permitted.
Single group
Gallium maltolate
Drugoral small-molecule iron mimetic
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.
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.
GaM PK levels
Measure serum gallium levels at multiple timepoints to calculate pharmacokinetic parameters in pediatric patients
Disease response
Document radiologic stabilization, improvement, or progression in the size of recurrent or relapsed HGGs and ATRTs as assessed by consensus recommendations from the Response Assessment in Pediatric Neuro-Oncology (RAPNO) for pediatric high-grade gliomas, diffuse intrinsic pontine gliomas, and medulloblastoma and other leptomeningeal seeding tumors.
Survival
Document survival times to determine PFS and OS.
Quality of Life Patient Reported Outcomes
Document quality of life outcomes using validated quality of life measurements for pediatric patients (PROMIS®).
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Sarah Rumler
Lead sponsor
Medical College of Wisconsin
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
