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 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT00859495
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed malignant mesothelioma, \< 20% sarcomatoid type
* No radiographic or other imaging evidence of Stage IV (cardiac, mediastinal, peritoneal, other distant) disease.
* Ineligible for other high priority national or institutional study.
* Age \>18 years \[to physiologic 75 years\].
* Life expectancy \> 3 months.
* Performance status, PS 0-2 \[Karnofsky Performance Status, KPS=70-100 %\].
* Prior therapy allowed (one prior systemic regimen) meeting the following parameters.
* No prior chest radiation therapy within 6 weeks of treatment
* No prior chemotherapy regimens within four weeks of treatment
* Non pregnant, non-lactating. (serum HCG test will be performed in patients in whom there is a possibility of pregnancy.)
* Required initial laboratory data/clinical parameters (see also Sec. 8.0) White cell count: \>3000/ul. Platelet count: \>100,000/ul. Creatinine clearance: ≥ 45 ml/min Bilirubin: \< 2 x ULN SGOT or SGPT: \< 2 x ULN
* Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
* No other coexistent malignancy. However, curatively treated or fully controlled solid tumors (other than mesothelioma) may be eligible if in the judgement of the PI, the benefit of treatment outweighs the risk.
* No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection, congestive heart failure, angina pectoris, cardiac arrhythmia(s), or uncontrolled hypertension). HIV status or other severe illnesses will be assessed using medical records.
Exclusion Criteria:
* If any of the inclusion criteria was not met.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00859495
Study Brief:
Protocol Section:
NCT00859495