Effect of FAS and FAS Ligand Polymorphisms on Patients With Platinum-Based -Treated Malignant Pleural Mesothelioma

Ain Shams University68 enrolled

Overview

To Study the Effect of Polymorphisms in Fas Ligand Gene Promoter Region (rs 763110) and Fas gene (rs1800682) on Platinum-Based regimens used in treatment of malignant pleural mesothelioma (MPM)

This study tries to find a correlation between single nucleotide polymorphisms (SNP) found in promoter region of Fas Ligand gene (rs 763110) and Fas (rs1800682) and clinical outcome on patients with MPM treated with platinum-Based agents as first line. the patients will have one of three following genotypes : Thymine/Thymine, Thymine/Cytosine or Cytosine/Cytosine (for Fas ligand polymorphism) and Adenine/Adenine, Adenine/Guanine or Guanine/Guanine ( for Fas polymorphism).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Malignant Pleural Mesothelioma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with histologically confirmed Malignant Pleural Mesothelioma * Age of 18 years or more. * first-line chemotherapy with platinum-Based agents Exclusion Criteria: * history of prior malignancy. * pregnancy or lactation or any other reason preventing him from taking platinum-Based chemotherapy (AST more than 2.5\* Upper Limit of Normal or Serum bilirubin more than 1.5\* Upper Limit of Normal)

Locations (1)

Ain Shams University Hospitals

Cairo, Abbasia, Egypt

Outcomes

Primary Outcomes

response rate

Tumor response will be evaluated after the third (initial evaluation response) and the sixth (confirmation of initial response) chemotherapy cycle according to the modified Response Evaluation Criteria in Solid Tumors. Patients will be assigned to one of following groups: complete response (CR), Partial response (PR), Stable disease (SD) and progressive disease (PD).

Time frame: After 6 cycles of chemotherapy (each cycle is 21 days )

Secondary Outcomes

progression free survival (PFS)

Progression-free survival (PFS) time is defined as the time from day 1 of chemotherapy to the day of documented disease progression or to death from any cause

Time frame: one year

overall survival (OS)

time is defined as the time from day 1 of chemotherapy to death from any cause.

Time frame: one year

estimation of treatment related toxicity

Hematologic (anemia, neutropenia, and thrombocytopenia) and non hematologic (nausea/vomiting, alopecia and nephrotoxicity) toxicities will be evaluated according to the National Cancer Institute-Common Toxicity Criteria. The worst degree of toxicity experienced throughout the treatment is used for the analysis. Toxicities of grade 2 or higher will be considered as clinically relevant.

Time frame: during the chemotherapy period, average duration 4 months

Data from ClinicalTrials.gov

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