Gallium Maltolate for Glioblastoma

MC
Overseen ByMedical College of Wisconsin Cancer Center Clinical Trials Office
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Medical College of Wisconsin
Must be taking: Temozolomide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how effectively gallium maltolate, a potential new treatment, reaches brain tumors in individuals with recurring glioblastoma, an aggressive brain cancer. Participants will take the treatment for 14 days before surgery to assess its penetration into the tumor. The trial seeks individuals who have already received standard treatments for glioblastoma, such as radiation and temozolomide chemotherapy, and have stable symptoms without recent worsening. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

You will need to stop taking oral iron supplements or iron chelators at least one week before starting the trial medication. The protocol does not specify other medication restrictions, but you should discuss your current medications with the study team.

Is there any evidence suggesting that gallium maltolate is likely to be safe for humans?

Research has shown that gallium maltolate (GaM) is generally safe for treating glioblastoma, a type of brain cancer. Studies have found that patients tolerate GaM well. Early results confirm its safety, with no major side effects reported.

In one study, patients who received GaM lived about 14 months, indicating effectiveness without causing serious harm. This outcome is a positive indicator of its safety.

These findings suggest that GaM could serve as a treatment option while maintaining a strong safety record.12345

Why do researchers think this study treatment might be promising for glioblastoma?

Gallium Maltolate is unique because it uses gallium, a metal that disrupts cancer cell metabolism by mimicking iron, which is essential for tumor growth. Unlike standard treatments for glioblastoma, such as temozolomide and radiation therapy, Gallium Maltolate offers a novel mechanism of action by specifically targeting the tumor's iron uptake processes. Researchers are excited about this approach because it could lead to more effective ways to halt tumor growth without affecting healthy cells as much as traditional therapies do.

What evidence suggests that gallium maltolate might be an effective treatment for glioblastoma?

Research has shown that gallium maltolate may help treat glioblastoma, a type of brain cancer. Studies have found that gallium maltolate can slow tumor growth and extend survival in animal tests. In one study, patients with recurring glioblastoma lived about 14 months on average after starting treatment with gallium maltolate. The treatment is usually well-tolerated and easily absorbed when taken orally. Early results suggest that gallium maltolate might benefit those with difficult-to-treat forms of this cancer. Participants in this trial will receive gallium maltolate for 14 days before surgical intervention.13467

Who Is on the Research Team?

RD

Rupen Desai, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for adults over 18 with recurrent glioblastoma who have already completed standard treatments like surgery, radiation, and temozolomide. Participants must be stable without new or worsening symptoms, have good organ function, not be pregnant or nursing, and able to take oral medication.

Inclusion Criteria

I have been diagnosed with glioblastoma (GBM).
I have had no new or worsening neurological symptoms for at least 14 days.
My brain tumor has been reviewed by a team of specialists and needs surgery for diagnosis.
See 9 more

Exclusion Criteria

Known hypersensitivity to or intolerance to gallium-based medications
I have a history of certain lung diseases.
I have not finished all standard treatments like surgery or radiation.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gallium maltolate for 14 days prior to surgical intervention

2 weeks
Outpatient basis

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Gallium Maltolate
  • Surgical Intervention

Trial Overview

The study tests how well an oral drug called gallium maltolate reaches brain tumors in people with recurrent glioblastoma before they undergo planned surgery. It is a Phase 0 trial focused on measuring drug levels in the tumor.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Gallium MaltolateExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Citations

Potent in vivo efficacy of oral gallium maltolate in treatment ...

Monotherapy with the iron-mimetic GaM profoundly inhibits trGBM growth and significantly extends disease-specific survival in vivo.

Oral Gallium Maltolate for Recurrent Glioblastoma

Rationale: Currently, recruitment has concluded for a Phase 1 trial assessing in patients with GBM. Preliminary analyses have demonstrated ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38288102/

Potent in vivo efficacy of oral gallium maltolate in treatment ...

Monotherapy with the iron-mimetic GaM profoundly inhibits trGBM growth and significantly extends disease-specific survival in vivo.

Research News in the Second Two-months of 2025

Among the 23 evaluable patients treated daily with GaM, the average overall survival was about 14 months from the start of therapy, a positive ...

Characterization of Response to Gallium Maltolate in ...

This project's research team has demonstrated the effectiveness of gallium maltolate (GaM), a newer generation compound with high oral bioavailability and ...

EXTH-134. Theoral iron mimetic gallium maltolate is ...

Recent in vitro data suggests that GaM may act as a radiosensitizer, which could dramatically change how brain tumors are treated. These ...

Imaging Biometrics Announces Successful Completion of ...

How does GaM's mechanism target glioblastoma? What safety data was observed in the Phase 1 trial?