Gallium Maltolate for Glioblastoma

Overseen By Medical 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

Must not be taking: Cytotoxic chemotherapy, Iron supplements

Disqualifiers: Active malignancy, Severe heart disease, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Rupen Desai, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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.

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.

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

How Is the Trial Designed?

Group I: Gallium Maltolate Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+