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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06057935
Phase
PHASE2
Status
Recruiting
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Conditions

  • Malignant Mesothelioma
  • Malignant Peritoneal Mesothelioma
  • Mesothelioma
  • Mesothelioma, Malignant
  • Peritoneal Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pemetrexed — DRUG
    Pemetrexed will be administered intravenously
  • Cisplatin — DRUG
    Cisplatin will be administered intravenously
  • Carboplatin — DRUG
    Possible substitution with carboplatin based on clinician discretion

Study Details

The purpose of this study is to find out whether intraperitoneal or intravenous chemotherapy given after cytoreductive surgery and HIPEC are effective treatments for people with malignant peritoneal mesothelioma. Outcomes will be compared by observing intraperitoneal versus intravenous treatments to analyze if one is better than the other.

Key Dates

Start date
Sep 21, 2023
Status verified
Jul 2025
Primary completion
Sep 21, 2028
Completion
Sep 21, 2028

Study Design

Enrollment
64 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IVC arm
    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.
  • Active Comparator: NIPC arm
    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.

Primary Outcome Measure

Progression Free Survival [ Time Frame: up to 24 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
University of Chicago (Data Collection Only)ChicagoIllinois60637
Hedy Kindler, MD
773-702-1470
University of Michigan (Data Collection Only)Ann ArborMichigan48109
Donnele Daley, MD
734-647-8902
Washington University (Data Collection Only)St LouisMissouri63110
Trang Nguyen, MD
314-362-2280
University of Nebraska (Data collection only)OmahaNebraska68198-7680
Jason Foster, MD
402-559-8941
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Garrett Nash, MD, MPH
212-639-8668
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Garrett Nash, MD
212-639-8668
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Garrett Nash, MD
212-639-8668
Rutgers University (Data Collection Only)New BrunswickNew Jersey08903
H. Richard Alexander, MD
732-235-6780
Memorial Sloan Kettering Commack (Limited Protocol Activities)CommackNew York11725
Garrett Nash, MD
212-639-8668
Memorial Sloan Kettering Westchester (Limited Protocol Activites)HarrisonNew York10604
Garrett Nash, MD
212-639-8668
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Garrett Nash, MD
212-639-8668
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Garrett Nash, MD
212-639-8668
Allegheny Health Network (Data Collection Only)PittsburghPennsylvania15212
Patrick Wagner, MD
833-246-7662

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By research site
University of Chicago (Data Collection Only)· Chicago, ILUniversity of Michigan (Data Collection Only)· Ann Arbor, MIWashington University (Data Collection Only)· St Louis, MOUniversity of Nebraska (Data collection only)· Omaha, NEMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJ

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