Oral Gallium Maltolate for Recurrent Glioblastoma

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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.