Intravenous Magnesium in Patients Receiving Cisplatin

NCT04481672 | Completed Phase 1 FDA Drug

• 1 other identifier: 19-801
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesothelioma

Keywords

Mesothelioma; Magnesium Sulfate; intraoperative cisplatin

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Magnesium Level

  Day of surgery through postoperative day 3.

• Tubular Injury Markers

  From admission through postoperative day 3

Study Arms (1)

Magnesium Sulfate

EXPERIMENTAL

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.

Drug: Magnesium Sulfate

Interventions

Magnesium Sulfate DRUG

Intravenous infusion of magnesium sulfate prior to intraoperative chemotherapy with cisplatin.

Magnesium Sulfate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Mesothelioma

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Shruti Gupta, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• David E. Leaf, MD, MMSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 22, 2020
• Study Start: July 30, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)