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:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT01212367
Eligibility Criteria:
Inclusion Criteria:
* evidence of progressive disease after standard first line treatment of mesothelioma; OR patient has refused standard first line treatment of mesothelioma
* evaluable disease
* No radiotherapy and/or treatment with chemotherapeutic, cytotoxic, or immunologic agents within 14 days prior to infusion of the IFN-α vector
* Must have a pleural space involved with tumor accessible for pleural catheter insertion
* FEV1\> 1 liter or 40% of predicted value
* Must have an anti-adenoviral neutralizing antibody titer equal to or less than 1:1000. This will be measured by the Penn Vector Core
Exclusion Criteria:
* Presence of HIV or Hepatitis B infection
* Use of concurrent systemic steroids, immunosuppressives, or any other medications that can directly or indirectly suppress the immune system
* Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependence, significant chronic obstructive pulmonary disease (COPD), end stage liver or renal disease
* Presence of untreated brain metastases
* Prior bone marrow or stem cell transplants
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01212367
Study Brief:
Protocol Section:
NCT01212367