Clinical Trials for Mesothelioma Patients: Immunotoxin Therapy Patient Characteristics

Read about the patient characteristics 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.

Patient Characteristics:
Inclusion criteria:
• Karnofsky performance status 70-100%
• Life expectancy > 3 months (assessed by the principal investigator)
• ALT, AST, or bilirubin = grade 1 (unless due to cancer or Gilbert disease) OR = grade 2 (if due to cancer)
• Serum creatinine clearance = 60 mL/min
• ANC = 1,500/mm^3
• Platelet count = 100,000/mm^3
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• FEV_1 = 50% of predicted value (post-pleural drainage and bronchodilation if these are indicated)
• Must be able to understand and sign informed consent
• Other (non-mesothelioma) cancers that meet eligibility criteria and have had less than 5 years of disease-free survival are considered on a case by case basis
• May only be enrolled in this study once (i.e., no second time or later cohort re-enrollment)

Exclusion criteria:
• Clinically significant heart disease (New York Heart Association class III or IV)
• Active bacterial or fungal infection
• Baseline coagulopathy = grade 3 (unless due to anticoagulant therapy)
• HIV-positive serology
• Hepatitis B surface antigen positivity
• Uncontrolled, symptomatic, intercurrent illness including, but not limited to, any of the following:
o Infections requiring systemic antibiotics
o Unstable angina pectoris
o Cardiac arrhythmia
o Psychiatric illness or social situation that would limit compliance with study requirements

Prior Concurrent Therapy:
• More than 4 weeks since prior radiotherapy (except palliative extra-thoracic localized radiotherapy) or biologic therapy for malignant pleural mesothelioma
• More than 2 weeks since prior surgery or pleurodesis
• No prior systemic chemotherapy for malignant pleural mesothelioma

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

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