Intravenous Magnesium in Patients Receiving Cisplatin

Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04481672
• Other study ID #: 19-801
• Status: Completed
• Phase: Phase 1
• Start date: July 30, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: January 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 >2.5 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.

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Malignant

Intervention

Drug:
• Magnesium Sulfate
Intravenous infusion of magnesium sulfate prior to intraoperative chemotherapy with cisplatin.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and acceptability as measured by participant rates of enrollment	Feasibility assessed by % of patients that agree to participate. Project feasible if >30% of the patients approached agree to participate	6 months
Primary	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0	NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	Time of magnesium infusion till 2 days.
Secondary	Magnesium Level	Assess the amount of IV magnesium needed to reach a target level of 3 to 4.8mg/dl. Magnesium levels will be measured at multiple time points. We want >80% (=32/40) of the time-averaged, postoperative magnesium levels to be within the target range of 3 to 4.8 mg/dl.	Day of surgery through postoperative day 3.
Secondary	Tubular Injury Markers	Changes in urinary KIM-1 and urinary NGAL levels in order to assess intra- and interassay variability	From admission through postoperative day 3