Trimodal Lung-Sparing Treatment of Pleural Mesothelioma

Stopped early · Phase 2

Conditions studied: Pleural Mesothelioma

In brief

The primary objective of the study is to determine the feasibility (as determined by lack of serious adverse events) and tolerability (as determined by patient's ability to complete the study) of a multimodal lung sparing regimen of surgery, interpleural and intravenous chemotherapy, and local P-32 irradiation for malignant pleural mesothelioma.

Key facts

Study ID

NCT00859495

Run by

Columbia University

People needed

9

Starts

2008-02-01

Expected to finish

2012-02-01

Last updated by the study team

2020-08-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• If any of the inclusion criteria was not met.

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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