Clinical trial · Interventional
Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma
Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin and Intravenous Sodium Thiosulfate in the Multimodality Treatment of Malignant Pleural Mesothelioma
NCT00165555CI-TRIAL-00014116completedPhase 1ClinicalTrials.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 purpose of this study it to determine the safety and maximally tolerated dose (MTD) of cisplatin administered in the operating room and put into the chest and abdomen for one hour. We are also looking at the effects of heating the chemotherapy to a temperature of 42 degrees celsius.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Mesothelioma | Pleural Malignant Mesothelioma | ALIAS | 0.90 |
| Pleural Mesothelioma | Pleural Mesothelial Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Sodium Thiosulfate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the maximally tolerated dose of intracavitary cisplatin in patients with malignant pleural mesothelioma,
- timeFrame
- 3 years
Secondary outcomes (2)
- measure
- To quantitate the safety of intraoperative intrathoracic/intraperitoneal hyperthermic cisplatin
- timeFrame
- 3 years
- measure
- to study the pharmacokinetics of cisplatin administered in this way.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologic confirmation of malignant pleural mesothelioma * Patients who are able to tolerate surgical cytoreduction but unable to undergo extrapleural pneumonectomy due to poor cardiopulmonary reserve or tumor invasion * 18 years of age or older * Malignancy is confined to the affected hemithorax. * Grossly normal cardiac function with an EKG showing no cardiomyopathy or acute changes * Evidence of adequate renal and hepatic function * Karnofsky performance status of 70% or greater Exclusion Criteria: * Extended disease outside the ipsilateral hemithorax as determined radiologically and intraoperatively * Distant metastases * Non-malignant systemic disease * Active concomitant malignancy * Psychiatric or addictive disorders which would preclude obtaining informed consent * Prior treatment within the last 2 months, other than surgical resection for their current malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.