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

Study Overview
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Brief Summary
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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)

Detailed Description
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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).

Official Title
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The Effect of FAS and FAS Ligand Genetic Polymorphisms on the Clinical Outcome of Patients With Malignant Pleural Mesothelioma Treated With Platinum-Based Regimens

Conditions
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Malignant Pleural Mesothelioma

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| people with MPM with Thymine/Thymine,Thymine/cytosine genotype<br>according to Single nucleotide polymorphism analysis of rs 763110, people have one of the following genotypes, Thymine/Thymine,Thymine/Cytosine,Cytosine/Cytosine. we will assign Thymine/Thymine, Thymine/Cytosine to group one and Cytosine/Cytosine to group two. for rs 1800682 people will have one of the following genotypes Adenine/Adenine, Adenine/Guanine or Guanine/Guanine. | |
| people with MPM, Cytosine/Cytosine genotype<br>according to Single nucleotide polymorphism analysis of rs 763110, people have one of the following genotypes, Thymine/Thymine,Thymine/Cytosine,Cytosine/Cytosine. we will assign Thymine/Thymine, Thymine/Cytosine to group one and Cytosine/Cytosine to group two. for rs 1800682 people will have one of the following genotypes Adenine/Adenine, Adenine/Guanine or Guanine/Guanine. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | After 6 cycles of chemotherapy (each cycle is 21 days ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | one year | 
| overall survival (OS) | time is defined as the time from day 1 of chemotherapy to death from any cause. | 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. | during the chemotherapy period, average duration 4 months |