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

• ClinicalTrials.gov Identifier: NCT02761863
• Recruitment Status: Unknown
• First Posted: May 4, 2016
• Last Update Posted: February 23, 2018
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Ahmed Nagy, Ain Shams University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Malignant Pleural Mesothelioma	Other: CD 74, VEGF detection

Study Design

• Study Type: Observational
• Estimated Enrollment: 100 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma Receiving Pemetrexed/Platinum Protocol
• Estimated Study Start Date: July 30, 2019
• Estimated Primary Completion Date: January 30, 2020
• Estimated Study Completion Date: July 30, 2021

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. CD 74 and VEGF detection effect on response to treatment [ Time Frame: Essay done before starting treatment and correlated with the response ]

   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.

Biospecimen Retention:   Samples Without DNA

Paraffin Blocks

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients suffering from Malignant Pleural Mesothelioma

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Ahmed Nagy, Dr, Ain Shams University
• ClinicalTrials.gov Identifier: NCT02761863
• Other Study ID Numbers: CURE001
• First Posted: May 4, 2016
• Last Update Posted: February 23, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Ahmed Nagy, Ain Shams University:

Mesothelioma; CD 74; VEGF

Additional relevant MeSH terms:

Mesothelioma; Mesothelioma, Malignant; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases