Clinical trial · Interventional
Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma
Phase I Dose-Escalation /Phase II Monocentric Open Trial for Evaluation of Safety and Efficacy of Intracavitary Cisplatin-Fibrin Localized Chemotherapy After Pleurectomy/Decortication or Extrapleural Pneumonectomy for the Treatment of Patients With 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)
The aim is to introduce a new therapeutic method of intracavitary chemotherapy (cisplatin) combined with a fibrin carrier (Vivostat®) after pleurectomy/decortication or extrapleural pneumonectomy in a phase I and II study for Malignant Pleural Mesothelioma patients by evaluation of the safety in a dose-escalating model (phase I), and confirmation of safety and efficacy in phase II with the maximum tolerated dose in phase I.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intracavitary cisplatin-fibrin | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intracavitary cisplatin-fibrin
- description
- single dose local intracavitary cisplatin-fibrin application after pleurectomy/decortication
- interventionNames
- Combination Product: intracavitary cisplatin-fibrin
Primary outcomes (2)
- measure
- Incidence of Treatment-Emergent Adverse Events (Safety)
- timeFrame
- during 6 weeks after surgery with local cisplatin-fibrin application
- description
- (Serious) Adverse Events \& safety blood parameters (hematology and clinical chemistry)
- measure
- Cisplatin concentration in the superficial chest wall tissue
- timeFrame
- 90 min after application
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Patient is able to understand and willing to sign a written informed consent document. * Male or female, age \>=18 years * ECOG performance status =\<2 (ECOG = Eastern Cooperative Oncology Group) * Resectable MPM (Malignant Pleural Mesothelioma) histologically confirmed (phase I: stage cT1-cT4 cN0-cN3 cM0-cM1 / phase II: stage cT1-cT3 cN0-cN1 cM0) (TNM Tumor staging abbreviations: c = clinical; T = Tumor, N = lymph Nodes, M = Metastases; numbers = quantity) * Only Phase II: Mediastinal staging (cytological or histological) * Only Phase II: Induction chemotherapy (3 or more cycles cisplatin or carboplatin (also in combination with other therapeutic agents) * Patient qualifying for (extended) pleurectomy/decortication ((e)P/D) or extrapleural pneumonectomy (EPP) for resection of MPM, which has to be assessed during a multidisciplinary tumor board including a thoracic surgeon * Patient must have appropriate organ and bone marrow function as defined: hematologic function: hemoglobin ≥100 g/L, WBC (white blood cell count) ≥3.5 G/L, neutrophils ≥1.5 G/L, thrombocytes ≥100 G/L; liver function: total bilirubin and LDH (lactate dehydrogenase) ≤1.5 x ULN (upper limit of normal); AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gamma glutamyltransferase), and AP (alkaline phosphatase) ≤2.5 x ULN; renal function: creatinine ≤130 μmol/L or, if greater, creatinine clearance ≥60 ml/min/1.73m2. * Patient must have an appropriate blood coagulation for P/D or EPP (Quick-test \> 50%, INR (international normalized ratio) \<=1.2) * The patient agrees to use an efficient contraceptive treatment up to 3 months after cisplatin application if required (pre-menopausal women and men in a sexually mature age). * Heart and lung function allowing P/D under general anesthesia Exclusion criteria: * Known or suspected unwillingness of the patient to follow the rules of the protocol * Patient who has not recovered from side effects from prior chemotherapy or radiotherapy. * Any known hypersensitivity against cisplatin or other platinum containing substances or any other components used for the preparation of the drugs. * Patient must not receive any other investigational agents 4 weeks before treatment and until the end of the observation period (2 months after treatment). * Patient with prior ipsilateral pleurectomy * Only Phase II: Multimodality Prognostic Score (MMPS) \> 2: 4 items with a maximum possible score of 4 if the patient presented all four conditions and 0 if none were present: Tumor volume before induction chemotherapy \> 500 ml, non-epithelioid histotype in the diagnostic biopsy before induction chemotherapy, CRP (C reactive protein) value \> 30 mg/l before induction chemotherapy, and progressive disease after induction chemotherapy according to RECIST criteria * Patient with uncontrolled intercurrent illnesses that would limit the operative procedure of P/D / EPP or compliance with study requirements * Tinnitus impairment of more than severity grade I (slight) evaluated by the tinnitus questionnaire MiniTF12\_CH (Mini Tinnitus Fragebogen 12, CH = Confoederatio Helvetica (Swiss version)), and/or restricted power of hearing until 4 kHz (kilohertz) confirmed by audiometry, unless age-related presbyacusis in a normal range confirmed by an audiologist. * Known alcohol and/or drug abuse at the time of screening * Pregnant or lactating woman
References
Publications (0)
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