Oral Gallium Maltolate for Recurrent Glioblastoma

NCT07515924 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: IIT-DESAI-GBM-GALLIUMMALTOLATE
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 0 investigational study to assess the central nervous system penetration and tumoral concentration of gallium in patients with recurrent glioblastoma administered with preoperative gallium maltolate.

Conditions

Glioblastoma

Keywords

glioblastoma; Gallium Maltolate

Outcome Measures

Primary Outcomes (1)

• Glioma Tissue Difference

  The difference in gallium concentration between glioma tissue resected from patients treated with gallium maltolate and matched glioma tissue from untreated patients from a tumor bank registry, matched based on age, pathology, and gender. The measure type will be mean reported with standard deviation.

  3 months

Study Arms (1)

Gallium Maltolate

EXPERIMENTAL

Gallium Maltolate will be administered on an outpatient basis. Subjects will take it for 14 days prior to surgical intervention.

Drug: Gallium Maltolate; Procedure: Surgical Intervention

Interventions

Gallium Maltolate DRUG

Gallium Maltolate will be administered at a total daily dose of 2500 mg.

Also known as: CAS 108560-70-9

Gallium Maltolate

Surgical Intervention PROCEDURE

Patients will be scheduled for surgical intervention (needle biopsy or resection) as deemed necessary by the clinical team after 14 ± 5 days of oral Gallium Maltolate administration.

Gallium Maltolate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• All subjects must have a prior histological diagnosis of Glioblastoma (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).
• Subjects are required to have received standard treatment which consists of radiotherapy and temozolomide (i.e., the Stupp Protocol). Treatment with adjuvant temozolomide 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 absolute neutrophil count (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.
• Subjects must be symptomatically stable, without new or rapidly worsening neurologic deficits for a minimum of 14 days prior to screening.
• Subjects must have been reviewed by a multidisciplinary group comprised of Central Nervous System oncology experts (which could include neuro-oncology, radiation oncology, neurosurgery, and radiology) to have radiographic signs of tumor progression (as defined by the RANO criteria) requiring surgical pathologic specimen (stereotactic biopsy or craniotomy for debulking/resection).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Subjects must have adequate bone marrow function as evidenced by:
• an ANC of \>1500/μL (stable off any growth factor within one week of study drug administration)
• Hemoglobin \> 9 g/dL
• Platelet count \> 100,000/μL without transfusion within one week
• Subjects must have adequate hepatic and renal function based on the following laboratory tests:
• Alanine aminotransferase (ALT) ≤ 2 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) ≤ 2 x ULN
• Alkaline phosphatase ≤ 2 x ULN

You may not qualify if:

• 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.
• Prior chemotherapy or radiotherapy within 14 days of study entry.
• 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 (New York Heart Association Class 3 or 4) or known lung (forced expiratory volume (FEV) \<50%) disease, uncontrolled diabetes mellitus.
• 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.
• Subjects who have not completed all standard-of-care treatments including surgical procedures and radiation therapy.
• Subjects with new or worsening neurologic deficits that would require surgical treatment before complete administration of the study drug.
• Inability to tolerate an oral medication or keep pills down.
• Subjects who are pregnant or nursing.
• Subjects with any condition which, in the investigator's opinion, makes the patient unsuitable for study participation.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

gallium maltolate; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Rupen Desai, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)