Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT01445392
Eligibility Criteria:
* INCLUSION CRITERIA:
Subjects must meet all of the following criteria to be eligible to participate in the study:
Subjects must have histologically confirmed epithelial or biphasic pleural mesothelioma not amenable to potentially curative surgical resection. However, patients with biphasic tumors that have a predominantly sarcomatoid component will be excluded.
Measurable disease
Subjects must be greater than or equal to 18 years old
Karnofsky Performance Status (KPS) of greater than or equal to 70
Life expectancy of greater than 3 months, as assessed by the principal investigator.
Adequate organ function with:Hepatic function: serum transaminases (either ALT or AST) or bilirubin, less than or equal to Grade 1, unless due to cancer or Gilbert s disease; less than or equal to Grade 2, if due to cancer
Renal function: serum creatinine clearance greater than or equal to 60mL/min as estimated by Cockroft-Gault formula.
Bone marrow function: ANC of at least 1,500/mm (3), Platelet count at least 100,000/mm (3)
Pulmonary Function: FEV (1) greater than or equal to 50 percent of predicted value (post-pleural drainage and bronchodilation if these are indicated)
Must be able to understand and sign informed consent
Female and male subjects agree to use an approved method of contraception during the study
EXCLUSION CRITERIA:
Subjects must not be pregnant or breast feeding
Prior radiotherapy (except palliative extra-thoracic localized radiotherapy) or biologic therapy for malignant pleural mesothelioma within 4 weeks
Prior systemic chemotherapy for malignant pleural mesothelioma
Documented and ongoing central nervous system involvement with their malignant disease (history of CNS involvement is not an exclusion criterion but the CNS metastases should have been adequately treated (radiation or surgical resection) and subjects are free from symptoms for 3 months off steroids).
Clinically significant heart disease (New York Heart Association Class III or IV)
Active bacterial or fungal infection.
Baseline coagulopathy greater than or equal to Grade 3 unless due to anticoagulant therapy
Surgery or pleurodesis within 2 weeks
HIV positive serology (due to increased risk of severe infection and unknown interaction of SS1(dsFv)PE38 with antiretroviral drugs)
Hepatitis B surface antigen positivity
Subjects with other (non-mesothelioma) cancers who meet eligibility criteria and have had less than 5 years of disease-free survival will be considered on a case-by-case basis
Uncontrolled, symptomatic, intercurrent illness including but not limited to: infections requiring systemic antibiotics, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT01445392
Study Brief:
Protocol Section:
NCT01445392