Medical College of Wisconsin
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.
Rationale: Currently, recruitment has concluded for a Phase 1 trial assessing in patients with GBM. Preliminary analyses have demonstrated gallium maltolate is both safe and potentially efficacious in treating glioblastoma. However, while gallium maltolate has been well-tolerated, further correlative analyses are necessary to confirm the drug's ability to act within the brain.
Inclusion Criteria: 1. Age \>18 years 2. 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. 3. 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). 4. Subjects are required to have received standard treatment which consists…
Gallium Maltolate will be administered at a total daily dose of 2500 mg.
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.
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