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A Phase 1 Clinical Trial of Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma

Protocol No
IIT-CONNELLY-GBM-GAMAY
Principal Investigator
Jennifer Connelly
Phase
I
Summary
This study is for persons with recurrent glioblastoma that has failed to respond to or has come back after standard radiotherapy and Temozolomide treatment. The overall goal of this study is to develop Gallium Maltolate (GaM), an experimental drug, as a new oral treatment for patients with glioblastoma brain tumors whose tumor has relapsed after initial treatment or has progressed despite initial treatment. The study is based on laboratory research which shows that GaM can shrink the growth of glioblastoma tumors in animals. The purpose of this Phase I study is to determine the dose of GaM that can be tolerated by patients when taken by mouth (orally) and to see whether gallium maltolate can shrink their tumors. GaM is investigational, meaning it is not approved by the FDA for the treatment of glioblastoma.
Description
This study is for persons with recurrent glioblastoma that has failed to respond to or has come back after standard radiotherapy and Temozolomide treatment. The overall goal of this study is to develop Gallium Maltolate (GaM), an experimental drug, as a new oral treatment for patients with glioblastoma brain tumors whose tumor has relapsed after initial treatment or has progressed despite initial treatment.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL