Intravenous Magnesium in Patients Receiving Cisplatin

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This research study, is trying to determine the highest dose of magnesium that can be given safely to people with malignant mesothelioma receiving intraoperative chemotherapy with cisplatin who are at risk for acute kidney injury.

The name(s) of the study drug involved in this study is

• magnesium sulfate.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Treatments: Magnesium Sulfate

Criteria

Inclusion Criteria:

• Adults ≥18 years with malignant mesothelioma admitted for HIOCC. Because no dosing or adverse event data are currently available on the use of intravenous magnesium participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric studies.

• Glomerular filtration rate (GFR)≥ 30 ml/min/1.73m2 at the time of enrollment

• Patients must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients with a pre-treatment serum Magnesium level >2.8 mg/dl or <1.3 mg/dl at the preoperative visit

• Patients with AKI at the time of enrollment, assessed by Kidney Disease Improving Outcomes Criteria (serum creatinine increase ≥1.5x baseline)

• Patients with estimated glomerular filtration rate <30 ml/min/1.73m2 at the time of enrollment

• Patients with neuromuscular disease (e.g., amyotrophic lateral sclerosis, multiple sclerosis, muscular dystrophy, myasthenia gravis, myositis)

• Patients with sustained bradycardia (heart rate <50 beats per minute on 1 or more EKGs in the preceding 90 days) or 2nd degree AV heart block type 2 or higher with the absence of a functioning pacemaker

• Participants who are receiving any other investigational agents.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to intravenous magnesium

• Participants with uncontrolled intercurrent illness.

• Participants with psychiatric illness/social situations that would limit compliance with study requirements.

• Pregnant women are excluded from this study because they may need magnesium for treatment of preeclampsia or eclampsia, apart from this study.