Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma

Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma Receiving Pemetrexed/Platinum Protocol

This is a prospective study evaluating the effect of expression of CD74 and VEGF on outcome of treatment in patients with malignant pleural mesothelioma receiving Pemetrexed/Platinum protocol. The paraffin blocks of the patients will be tested for CD74 and VEGF before starting treatment using IHC and the results will be correlated with the outcome of treatment during evaluation.

Study Overview

• Status: Unknown
• Conditions: Malignant Pleural Mesothelioma
• Intervention / Treatment: Other: CD 74, VEGF detection

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients suffering from Malignant Pleural Mesothelioma

Description

Inclusion Criteria:

1. Histologic or cytologic diagnosis of malignant pleural Mesothelioma
2. No prior chemotherapy.
3. ECOG less than or equal to 2 .
4. Measurable disease according to the requirements of SWOG criteria.
5. Age ≥ 19 years .
6. Estimated life expectancy of at least 12 weeks .
7. Adequate bone marrow reserve (white blood cells [WBC] ≥ 3.5 × 109 /L, neutrophils ≥ 1.5 × 109 /L, platelets ≥ 100 × 109 /L, and hemoglobin ≥ 9.0 gm/dL).

Exclusion Criteria:

1. Presence of central nervous system metastases.
2. Inadequate liver function (bilirubin > 1.5 times upper normal limit [UNL] and alanine transaminase [ALT] or aspartate transaminase [AST] > 3.0 UNL or up to 5.0 UNL in the presence of hepatic metastases).
3. Inadequate renal function (creatinine > 1.25 times UNL, creatinine clearance < 50mL/min).
4. Serious concomitant systemic disorder incompatible with the study.
5. Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence).
6. Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

CD74 - VEGF arm

Other: CD 74, VEGF detection; All MPM samples will be subjected to immunohistochemistry with CD74 and VEGF antibodies. The VEGF will be scored using a 0-3 scoring system to represent the percentage of cytoplasmic positively stained cells in the tumor portion, as follows: 0-10%, 11-30%, 31-60% and 61-100% positive staining correspond to score 0, 1, 2 and 3 respectively. Both CD74 and VEGF immunohistochemical markers will be furtherly categorized in the statistical analyses as none (0)/low (1) vs medium (2)/high expression(3). The CD74 expression will be recorded in the tumor and the stroma semiquantitatively using the histoscore method using four representative fields with the final score resulting from the percentage of tumor cells staining positively multiplied by the staining intensity grade.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD 74 and VEGF detection effect on response to treatment	The paraffin blocks of the patients will be tested for CD74 and VEGF before starting treatment using IHC and the results will be correlated with the outcome of treatment during evaluation. All MPM samples will be subjected to immunohistochemistry with CD74 and VEGF antibodies. The VEGF will be scored using a 0-3 scoring system to represent the percentage of cytoplasmic positively stained cells in the tumor portion, as follows: 0-10%, 11-30%, 31-60% and 61-100% positive staining correspond to score 0, 1, 2 and 3 respectively. Both CD74 and VEGF immunohistochemical markers will be furtherly categorized in the statistical analyses as none (0)/low (1) vs medium (2)/high expression(3). The CD74 expression will be recorded in the tumor and the stroma semiquantitatively using the histoscore method using four representative fields with the final score resulting from the percentage of tumor cells staining positively multiplied by the staining intensity grade.	Essay done before starting treatment and correlated with the response

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 30, 2019
• Primary Completion (Anticipated): January 30, 2020
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: VEGF; Mesothelioma; CD 74
• 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: CURE001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No