Clinical trial · Interventional
Trimodal Lung-Sparing Treatment of Pleural Mesothelioma
Phase II, A Study of Lung-Sparing Combined Modality Protocol for the Treatment for Malignant Pleural Mesothelioma: The Columbia Protocol
NCT00859495CI-TRIAL-00046801terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pleural Mesothelioma | Pleural Mesothelial Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multimodal lung sparing regimen
- description
- Intrapleural chemotherapy plus systemic chemotherapy: Thoracoscopy to implant two intrapleural catheters followed by intrapleural chemotherapy with doxorubicin and cisplatin (weeks 1, 2, 4, 5, 7, and 8). Systemic chemotherapy treatments with cisplatin and pemetrexed during weeks 3, 6, and 9. Intrapleural radiotherapy with P-32 will be given 3 weeks after last dose of chemotherapy and 11 to 12 weeks after initial thoracoscopy.
- interventionNames
- Drug: Doxorubicin
- Drug: Cisplatin
- Drug: Pemetrexed
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Number of Subjects Who Were Able to Complete Trimodal Therapy (Combination of Surgery, Intrapleural and Systemic Chemotherapy and P-32 Radiotherapy).
- timeFrame
- 20 weeks
- description
- To determine the feasibility of multimodal lung sparing regimen. Intrapleural chemotherapy (12 weeks) will be administered within two weeks after surgery. Approximately 30 days post last dose of chemotherapy (+/- 14 days), the patient should be reassessed for resolution of any treatment-related toxicity which may have occurred during the course of study participation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.