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Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma

NCT02611037 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-12-18

Study results available
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Summary

The purpose of this study is to determine whether the transarterial chemoperfusion treatment with cisplatin, methotrexate and gemcitabine is safe and effective in adults with malignant pleural mesothelioma (MPM).

Conditions

Interventions

DRUG

Cisplatin

The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin.

DRUG

Methotrexate

The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2).

DRUG

Gemcitabine

The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine.

OTHER

Lung Cancer Symptom Scale for Mesothelioma Questionnaire

Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Bela Kis, M.D., Ph.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-04
Primary Completion
2021-10-16
Completion
2024-01-26

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02611037 on ClinicalTrials.gov