Clinical trial · Interventional
Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma
A Phase I Trial of Extrapleural Pneumonectomy/Pleurectomy Decortication, Intrathoracic/Intraperitoneal Hyperthermic (IOHC) Cisplatin and Gemcitabine With Intravenous Amifostine and Sodium Thiosulfate Cytoprotection for Patients With Resectable Malignant Pleural Mesothelioma
- 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)
RATIONALE: After removal of visible cancer in the chest, chemotherapy drugs are used to kill or stop tumor cells from dividing, so that they stop growing or/and die. Cisplatin is currently used safely as in intra-operative treatment for malignant pleural mesothelioma. This study is aimed to determine if the addition of gemcitabine as a second intracavitary chemotherapy can be accomplished safely. PURPOSE: This is a Phase I trial to study the efficacy of combination chemotherapy consisting of gemcitabine and 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 and the effect of cytoprotection agents: amifostine and sodium thiosulfate to counteract potential side effects of chemotherapy.
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 |
|---|---|---|---|
| Malignant Pleural Mesothelioma | Pleural Malignant Mesothelioma | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amifostine | Drug | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Extrapleural pneumonectomy (EPP) | Procedure | — | UNRESOLVED |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| Pleurectomy/Decortication | Procedure | — | UNRESOLVED |
| sodium thiosulfate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Extrapleural pneumonectomy (EPP)
- description
- This is dose escalation 3+3 study design. All the patients meet the eligibility criteria and then sign the informed consent. Then after they have completed their standard pre-operative evalutions were each brought to the operating room for this surgical resection. Regardless of the arm the subject is assigned to they all recieve surgical intervention (Extrapleural Pneumonectomy, Pleurectomy/Decortication, or Tumor Debulking), Amifostine, Cisplatin, Gemcitabine, and Sodium Thiosulfate
- interventionNames
- Procedure: Extrapleural pneumonectomy (EPP)
- Drug: Cisplatin
- Drug: gemcitabine
- Drug: amifostine
- Drug: sodium thiosulfate
- type
- EXPERIMENTAL
- label
- Pleurectomy/Decortication (P/DC)
- description
- This is dose escalation 3+3 study design. All the patients meet the eligibility criteria and then sign the informed consent. Then after they have completed their standard pre-operative evalutions were each brought to the operating room for this surgical resection. Regardless of the arm the subject is assigned to they all recieve surgical intervention (Extrapleural Pneumonectomy, Pleurectomy/Decortication, or Tumor Debulking), Amifostine, Cisplatin, Gemcitabine, and Sodium Thiosulfate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-proven diagnosis of stages I to III malignant mesothelioma of the pleura and negative mediastinal N2 lymph nodes (Malignancy is confined to the affected hemithorax) * Adequate organ function including the following: adequate cardiac function, pulmonary function, renal and hepatic function and bone marrow reserve * Adequate overall physical activity * Surgical candidate for cytoreductive surgery Exclusion Criteria: * Extended disease outside the ipsilateral hemithorax as proven histologically, radiologically and/or intraoperatively * Have received chemotherapy and or radiation therapy within the last 3 years at the time of study entry * Serious concomitant systemic disorders * Second active primary malignancy (to exclude non- melanoma skin cancer) * Pregnancy at the time of the operation * Psychiatric or addictive disorder which would preclude obtaining informed consent
References
Publications (0)
Data not yet available