This phase I trial evaluates the side effects and best dose of intravenous magnesium in patients with malignant mesothelioma who are receiving cisplatin during surgery. Patients with lower blood magnesium levels are at higher risk of acute kidney injury. This study may help doctors learn more about the effect of intravenous magnesium administration on blood magnesium levels and determine the best dose(s) of intravenous magnesium to administer to patients with malignant mesothelioma.
Additional locations may be listed on ClinicalTrials.gov for NCT04481672.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the safety and tolerability of intravenous magnesium in patients with malignant mesothelioma receiving cisplatin intraoperatively and who are at risk for acute kidney injury.
SECONDARY OBJECTIVE:
I. To collect blood and urine samples in order to measure markers of tubular injury.
OUTLINE: This is a dose-escalation study.
Patients receive magnesium sulfate intravenously (IV) over 36 hours in the absence of disease progression or unacceptable toxicity.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorShruti Gupta