NCT04481672

Intravenous Magnesium in Patients Receiving Cisplatin

Pilot and Feasibility Study of Intravenous Magnesium in Patients Receiving Hyperthermic Intraoperative Chemotherapy With Cisplatin (HIOCC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This research study is a phase 1 pilot study, which is the first time investigators are examining larger doses of magnesium in patients receiving cisplatin and the effect of intravenous magnesium administration on blood magnesium levels. In previous studies it was found that patients with lower blood magnesium levels were at higher risk of acute kidney injury. The study is looking to determine the best dose(s) of intravenous magnesium to administer safely without severe or unmanageable side effects in participants. The purpose of the study is also to determine the dose of intravenous magnesium needed to achieve a target level. The U.S. Food and Drug Administration (FDA) has not approved magnesium for people with mesothelioma receiving cisplatin but it has been approved for other uses. The research study procedures include: screening for eligibility and study treatment at participant's preoperative visit with their thoracic surgeon. Intravenous magnesium will be administered in the hospital, the night prior to surgery, and take place over 36 hours. Participants will followed for 4 days on postoperative days 1, 2, and 3. It is expected that about 10 people will take part in this research study.

Conditions

• Mesothelioma

Interventions

Type	Name	Description
DRUG	Magnesium Sulfate	Intravenous infusion of magnesium sulfate prior to intraoperative chemotherapy with cisplatin.

Timeline

• Start date: 2021-07-30
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2020-07-22
• Last updated: 2022-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study