Status:
COMPLETED
Intravenous Magnesium in Patients Receiving Cisplatin
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
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 admi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04481672
Start Date
July 30 2021
End Date
December 30 2021
Last Update
January 11 2022
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215