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Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma

A Phase 1 Clinical Trial of Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma

NCT04319276•Medical College of Wisconsin

Summary

This is a phase 1 investigational study to assess the safety and preliminary efficacy of oral gallium maltolate (GaM) in participants with relapsed glioblastoma (GBM).

Detailed Description

This is a prospective, single-center, single-arm, open-label phase 1 study to determine the antineoplastic activity, safety and tolerance of GaM in participants with relapsed, treatment-refractory GBM. Although GaM has been studied in previous phase 1 clinical trials in normal individuals and in participants with a variety of different solid tumors, it has never been evaluated in this population of participants. Dosages in this study have been defined to have limited side effects in other phase 1 trials. The maximum number of participants to enroll in the dose escalation part will not exceed 36. The trial will follow a 3 + 3 phase I dose escalation design.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
•2. All patients must have a prior histological diagnosis of GBM (WHO grade IV) or molecular features of GBM (per the 6th volume of Central Nervous System Tumors in the 5th edition of the WHO Classification of Tumors).
•3. Patients are required to have received standard treatment which consists of radiotherapy and temozolomide \[i.e., the Stupp Protocol (3)\] Treatment with adjuvant temozolimide must be completed at least four weeks prior to GaM administration to avoid potential for overlapping toxicity with GaM. Although the half-life (T½) of temozolomide is 1.8 hours and it would be expected to be cleared by five half-lives, some patients receiving temozolomide may experience a delayed suppression of their ANC. Hence, a four-week interval between completion of temozolomide and GaM will be required. There is no maximum limit to the amount of chemotherapy or radiation patients have received prior to enrollment.
•4. Patients must have measurable disease that can be assessed for response to treatment as defined by the Response Assessment in Neuro-Oncology (RANO) criteria which incorporates MRI assessment and clinical factors. In the absence of measurable disease, pathologic confirmation of recurrent disease is required.
•5. Male or female subjects must be ≥18 years of age.
•6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
•7. Patients must have adequate bone marrow function as evidenced by:
•1. an absolute neutrophil count (ANC) of \>1500/μL (stable off any growth factor within one week of study drug administration
•2. Hemoglobin \> 9 g/dL
•3. Platelet count \> 100.000/μL without transfusion within one week
+10 more criteria

Exclusion Criteria

•1. Presence of other active malignant disease diagnosed within 12 months, with the exception of adequately treated non-melanoma skin cancer, adequately treated melanoma grade 2 or less, or cervical intraepithelial neoplasia. Active malignancy is malignancy receiving treatment.
•2. Prior chemotherapy or radiotherapy within 14 days of study entry.
•3. Known hypersensitivity to or intolerance to gallium-based medications.
•4. Concurrent use of cytotoxic chemotherapy is not permitted.
•5. Unstable or severe concurrent medical conditions such as severe heart (New York Heart Association Class 3 or 4) or known lung (FEV \<50%) disease, uncontrolled diabetes mellitus.
•6. 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.
•7. Patients who have not completed all standard-of-care treatments including surgical procedures and radiation therapy.
•8. Inability to tolerate an oral medication or keep pills down.
•9. Patients who are pregnant or nursing.
•10. Patients with any condition which, in the investigator's opinion, makes the patient unsuitable for study participation.

Locations (1)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

November 11, 2022

Primary Completion Date

February 13, 2025

Completion Date

March 1, 2027

Last Updated

November 3, 2025

Enrollment

ACTUAL participants

Conditions

Glioblastoma

Interventions

Gallium maltolate (500 mg)

DRUG

Gallium maltolate (1,000 mg)

DRUG

Gallium maltolate (1,500 mg)

DRUG

Gallium maltolate (2,000 mg)

DRUG

Gallium maltolate (2,500 mg)

DRUG

Gallium maltolate (recommended phase 2 dose)

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITING

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

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