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Intravenous Magnesium in Patients Receiving Cisplatin

Primary Purpose

Mesothelioma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Magnesium Sulfate

About this trial

This is an interventional supportive care trial for Mesothelioma focused on measuring Mesothelioma, Magnesium Sulfate, intraoperative cisplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnesium Sulfate

Arm 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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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.

Tubular Injury Markers

Changes in urinary KIM-1 and urinary NGAL levels in order to assess intra- and interassay variability

Full Information

NCT ID

NCT04481672

First Posted

July 19, 2020

Last Updated

January 10, 2022

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT04481672

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

July 30, 2021 (Actual)

Primary Completion Date

December 30, 2021 (Actual)

Study Completion Date

December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mesothelioma

Keywords

Mesothelioma, Magnesium Sulfate, intraoperative cisplatin

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Magnesium Sulfate

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Magnesium Sulfate

Intervention Description

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

Primary Outcome Measure Information:

Title

Feasibility and acceptability as measured by participant rates of enrollment

Description

Feasibility assessed by % of patients that agree to participate. Project feasible if >30% of the patients approached agree to participate

Time Frame

6 months

Title

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0

Description

NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time Frame

Time of magnesium infusion till 2 days.

Secondary Outcome Measure Information:

Title

Magnesium Level

Description

Time Frame

Day of surgery through postoperative day 3.

Title

Tubular Injury Markers

Description

Changes in urinary KIM-1 and urinary NGAL levels in order to assess intra- and interassay variability

Time Frame

From admission through postoperative day 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 >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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shruti Gupta, MD, MPH

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David E. Leaf, MD, MMSc

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing 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

Learn more about this trial

Intravenous Magnesium in Patients Receiving Cisplatin

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