Clinical Trials for Mesothelioma Patients: Immunotoxin Therapy Study Outline

Read about the study outline 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.

This is a dose-escalation study of SS1(dsFv)-PE38 immunotoxin. Patients receive SS1(dsFv)-PE38 immunotoxin IV over 30 minutes on days 1, 3, and 5, pemetrexed disodium IV over 10 minutes on day 1, and cisplatin IV over 2 hours on day 1 in courses 1 and 2. Beginning in course 3 and all subsequent courses, patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline, prior to course 2, and day 21 of course 2 for laboratory and pharmacokinetic studies. Samples are analyzed for the presence of anti-SS1(dsFv)-PE38 immunotoxin antibodies using a study drug-specific immunoassay and for concentrations of circulating mesothelin using enzyme-linked immunosorbent assay. Tumor cells from archival paraffin block biopsy specimens are analyzed for expression of mesothelin via immunohistochemistry.

Patients complete a quality of life questionnaire (i.e., LCSS-MESO) at baseline, after course 2, and subsequently after every even course to assess symptoms including appetite loss, fatigue, cough, dyspnea, and pain.

After completion of study treatment, patients are followed at 1, 3, 6, 12, 15, 18, 21, and 24 months.

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

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