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Clinical Trial Summary

This phase II trial studies how well brentuximab vedotin works in treating patients with CD30 positive (+) malignant mesothelioma that cannot be removed by surgery. Monoclonal antibodies, such as brentuximab vedotin, may interfere with the ability of tumor cells to grow and spread.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess 4-month disease control rate (DCR) in pre-treated patients with unresectable malignant pleural mesothelioma (MPM) treated with brentuximab vedotin.

SECONDARY OBJECTIVES:

I. To evaluate the response rate, progression-free and overall survival, and safety/toxicity of brentuximab vedotin in CD30+ malignant mesothelioma.

II. To prospectively evaluate the incidence of CD30+ expression in malignant mesothelioma during the screening process.

III. To determine whether CD30+ expression levels in tumor tissue correlate to response to brentuximab vedotin.

EXPLORATORY OBJECTIVES:

I. To collect archival or new tissue and blood for correlative studies. II. Next generation sequencing (NGS) will be conducted on adequate tumor tissue specimens.

III. Exploratory analysis: Bank peripheral blood at baseline for subsequent cytokine or reverse phase protein array (RPPA).

OUTLINE:

Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, 3 months, 6 months and then every 6 months thereafter. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03007030
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Anne S. Tsao
Phone 713-792-6363
Email [email protected]
Status Recruiting
Phase Phase 2
Start date April 5, 2017
Completion date April 30, 2022

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