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Chemotherapy for Mesothelioma

Q: How many locations have been designated to carry out this trial?

<p>Aside from the University of <a href="https://www.withpower.com/clinical-trials/nebraska">Nebraska</a>, which is only collecting data, there are 11 other sites engaging in various protocol activities for this trial. Memorial Sloan Kettering Basking Ridge and Monmouth have both been limited to specific protocols.</p>

Phase 2

Recruiting

Led By Garrett Nash, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Complete or near-complete CRS achieved

ECOG performance status ≤ 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial compares intraperitoneal vs. intravenous chemotherapy to determine which is more effective for people with mesothelioma.

Who is the study for?

This trial is for adults with malignant peritoneal mesothelioma who've had surgery to remove most of the cancer. They need good liver and kidney function, no severe unrelated medical issues, not pregnant or breastfeeding, and can't have used certain chemotherapies before.Check my eligibility

What is being tested?

The study tests if chemotherapy given directly into the abdomen (intraperitoneal) or through a vein (intravenous) after surgery helps patients more. It compares these two methods post-surgery to see which one might be more effective.See study design

What are the potential side effects?

Chemotherapy drugs like Carboplatin, Pemetrexed, and Cisplatin may cause nausea, fatigue, kidney problems, allergic reactions, blood cell count changes leading to increased infection risk or bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My surgery removed almost all of my cancer.

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I am fully active and can carry on all my pre-disease activities without restriction.

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My mesothelioma was confirmed to be epithelioid type during surgery.

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I have been diagnosed with MPM at this hospital.

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I am scheduled for surgery to remove all cancer from my abdomen.

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My kidney function is within the normal range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IVC armExperimental Treatment3 Interventions

Pemetrexed and cisplatin will be administered intravenously for a total of 4 to 6 cycles. Participants will receive 4 cycles, but can receive up to 6 cycles based on clinician discretion. Substitution with carboplatin allowed for pre-existing impairment of hearing, renal function, or neuropathy.

Group II: NIPC armActive Control3 Interventions

After completion of hyperthermic intraperitoneal chemotherapy/HIPEC, an intraperitoneal catheter with a subcutaneous reservoir will be inserted through the abdominal wall. When the participant's condition is considered stable by the physicians, the NIPC will be started. Pemetrexed and either cisplatin or carboplatin will be administered through the intraperitoneal port.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Pemetrexed

2014

Completed Phase 3

~5250

Cisplatin

2013

Completed Phase 3

~1940

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,834 Total Patients Enrolled

19 Trials studying Mesothelioma

733 Patients Enrolled for Mesothelioma

Garrett Nash, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA sanction intracaval administration of this treatment arm?

"Our internal evaluation places the IVC arm at a score of 2 because it is currently undergoing Phase 2 trials, meaning that there has been some proof for safety but no evidence yet on efficacy."

Answered by AI

Is enrollment in this research trial currently being accepted?

"This trial is actively searching for candidates, as indicated on clinicaltrials.gov. The study was uploaded to the website on September 21st 2023 and has since been updated once in accordance with its most recent date of modification - also falling upon 9/21/2023."

Answered by AI

How many locations have been designated to carry out this trial?

"Aside from the University of Nebraska, which is only collecting data, there are 11 other sites engaging in various protocol activities for this trial. Memorial Sloan Kettering Basking Ridge and Monmouth have both been limited to specific protocols."

Answered by AI

What is the present size of this medical trial's participant pool?

"Affirmative. Records on clinicaltrials.gov demonstrate that this trial, which first appeared on September 21st 2023, is actively recruiting participants. 64 individuals are needed from 11 separate locations to complete the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma

2023. "A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06057935.

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