Status:
TERMINATED
Trimodal Lung-Sparing Treatment of Pleural Mesothelioma
Lead Sponsor:
Columbia University
Conditions:
Pleural Mesothelioma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 mu...
Detailed Description
Current surgical and/or chemotherapeutic approaches for malignant pleural mesothelioma are unsatisfactory and have not been shown to significantly prolong survival, and often lead to worsened pulmonar...
Eligibility Criteria
Inclusion
- 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
- If any of the inclusion criteria was not met.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00859495
Start Date
February 1 2008
End Date
February 1 2012
Last Update
August 25 2020
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032