Clinical Trials for Mesothelioma Patients: Immunotoxin Therapy Study Objectives

Read about the study objectives for a current clinical trial being conducted to study the effects of Immunotoxin Therapy for patients who have been diagnosed with mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only. At this time, the study is currently being conducted only in Zurich, Switzerland.

Primary Objectives:
• To estimate the maximum tolerated dose (MTD) of SS1(dsFv)-PE38 immunotoxin when administered with pemetrexed disodium and cisplatin and to establish a safe dose, based on the MTD for subsequent clinical testing (phase II recommended dose) in patients with unresectable malignant epithelial pleural mesothelioma.
• To characterize the toxicity profile of SS1(dsFv)-PE38 immunotoxin.
• To study the clinical pharmacology (i.e., pharmacokinetics) which may dictate modification of SS1(dsFv)-PE38 immunotoxin schedule and administration in future studies.
• To observe antitumor activity, if any, especially in patients who receive SS1(dsFv)-PE38 immunotoxin at or near the MTD (or phase II recommended dose).

Secondary Objectives:
• To monitor antibody formation to SS1(dsFv)-PE38 immunotoxin and to assess the impact of these antibodies on SS1(dsFv)-PE38 immunotoxin pharmacokinetics (PKs).
• To investigate the potential of soluble mesothelin levels to predict PKs or any therapeutic or toxic response.
• To perform a pilot assessment of a validated quality of life instrument.

Courtesy of ClinicalTrials.gov, a service of the U.S. National Institutes of Health

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