Intravenous Magnesium in Patients Receiving Cisplatin

Brief Title

Intravenous Magnesium in Patients Receiving Cisplatin

Official Title

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

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 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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Feasibility and acceptability as measured by participant rates of enrollment

Secondary Outcome

 Magnesium Level

Condition

Mesothelioma

Intervention

Magnesium Sulfate

Study Arms / Comparison Groups

 Magnesium Sulfate

Description:  Starting the night before surgery participants will receive intravenous infusion of magnesium over approximately 36 hours. Dosage amounts will vary among participants as the study is determining the highest dose of magnesium that can be administered safely without severe or unmanageable side effects. The first 5 participants of the study will all receive the same dose of magnesium. The decision to test other doses of magnesium in 5 additional participants will depend on magnesium levels and dose tolerance outcomes in the first 5 participants.
Participants will be followed for 4 days and undergo blood test to measure magnesium levels at the time of hospital admittance, the morning prior to the surgery, twice immediately after surgery, and twice a day for 3 days after the surgery.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

10

Start Date

March 2021

Completion Date

March 2022

Primary Completion Date

May 2021

Eligibility 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 >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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Shruti Gupta, MD, MPH, 617-732-6383, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT04481672

Organization ID

19-801

Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Study Sponsor

Shruti Gupta, MD, MPH, Principal Investigator, Brigham and Women's Hospital

Verification Date

January 2021