Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients

Pharmacogenetics of Vinorelbine in Malignant Pleural Mesothelioma Patient

This is a multicenter retrospective analysis .The aim of the present study is to investigate the molecular predictors of vinorelbine response in tumor samples of a series of MPM patients and evaluate the possible impact on clinical outcome.

Sample size: around 150 patients based on the availability of tumor size

Study Overview

• Status: Completed
• Conditions: Malignant Pleural Mesothelioma

Detailed Description

Vinorelbine has recently become an alternative option for palliation in selected pemetrexed-pretreated patients with malignant pleural mesothelioma (MPM). However, nowadays there are no definitive data about vinorelbine predictors of response in MPM patients. The identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients.

In oncology a pharmacogenetic approach to customize the chemotherapy treatment according to individual as well as tumour genetic characteristics represents a modern and intriguing challenge. Recent studies have suggested that the expression levels of class III β-tubulin (TUBB3) or BRCA1, are related to a survival benefit from vinorelbine chemotherapy among patients with advanced solid malignancies, especially non-small cell lung cancer. There are no data about the predictive factors to vinorelbine in MPM patients. The identification of molecular predictors of effective therapy may allow in the future the development of better therapies.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Istituto Clinico Humanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Malignant pleural mesothelioma patients treated with vinorelbine as a second or later line chemotherapy with at least an objective response evaluation.

Description

Inclusion Criteria:

• MPM patients treated with vinorelbine in the ≥ second line setting will be retrospectively analyzed
• Patients will be selected based on the availability of tumor tissue

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR.	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Association of expression of TUBB3 and BRCA1 with clinical outcome (response, survival) .	2 months

Collaborators and Investigators

• Sponsor: Armando Santoro, MD

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: May 27, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimate): May 30, 2013

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Mesothelioma; Mesothelioma, Malignant
• Other Study ID Numbers: ONC/OSS-02/2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not planned