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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT01265433
Eligibility Criteria:
Inclusion Criteria:
* Pathologic diagnosis of malignant pleural mesothelioma (MPM) confirmed at participating institution.
* Positive immunohistochemical staining for WT-1 (greater than 10% of cells).
* Completion of multimodality therapy. This must include surgical resection by either pleurectomy/decortication or extrapleural pneumonectomy. The surgery should be performed with the intent of complete resection, though patients with an R1 resection will still be eligible. Patients should have also received treatment with chemotherapy and/or radiation. Patients with an R2 resection are also eligible as long as the site of residual disease is treated post-operatively with radiotherapy.
* 4-12 weeks since completion of combined modality therapy.
* Age \> or = to 18 years
* Karnofsky performance status \> or = to 70%
* Hematologic parameters: Absolute neutrophil count \> or = to 1000/mcL, Platelets \> or = to 50K/mcL.
* Biochemical parameters: Total bilirubin \< or = to 2.0 mg/dl, AST and ALT \< or = to 2.5 x upper limits of normal, Creatinine \< or = to 2.0 mg/dl.
Exclusion Criteria:
* Pregnant or lactating women.
* Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments.
* Patients with a serious unstable medical illness or another active cancer.
* Patients taking systemic corticosteroids.
* Patients with an immunodeficiency syndrome.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01265433
Study Brief:
Protocol Section:
NCT01265433