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Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Zurich
Swiss National Science Foundation
Swiss Accident Insurance Fund SUVA
Information provided by (Responsible Party):
University of Zurich Identifier:
First received: July 17, 2012
Last updated: May 10, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Malignant Pleural Mesothelioma
Drug: intracavitary cisplatin-fibrin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PhaseI Dose-Escalation /PhaseII 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

Resource links provided by NLM:

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • number of participants with adverse events [ Time Frame: during 4 weeks after surgery with local cisplatin-fibrin application ]
  • local cisplatin concentration in the superficial chest wall tissue by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection [ Time Frame: 90 min after application ]
  • safety blood parameters (hematology and clinical chemistry) [ Time Frame: baseline and 1, 2, 3, 4, 5, 7, 10, 14 days postoperatively ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: up to 5 years (phase I), up to 2 years (phase II) ]
  • FFR freedom from recurrence = time to tumor progression by CT or PET-CT/MRI [ Time Frame: 4, 16 weeks, then every 4 months up to 5 (phase I) / 2 years (phase II) ]
  • change from baseline in SF-36 quality of life questionnaire [ Time Frame: phase I: 0, 4, 8, 16 weeks and every 4w up to 5y; phase II: 0, 6, 16w and every 4w up to 2y ]
  • change from baseline in EORTC Lung Cancer Questionnaire QLQ-C15/LC13 [ Time Frame: phase I: 0, 4, 8, 16 weeks and every 4w up to 5y; phase II: 0, 6, 16w and every 4w up to 2y ]
  • cisplatin concentration in blood serum by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection [ Time Frame: baseline, and 0, 2, 6, 10, 24, 48, 120 h postoperative ]

  • cisplatin concentration in urine by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection [ Time Frame: baseline, collection of first 48h, day 14 postoperative ]

  • TUNEL assay (markers for apoptosis in superficial chest wall tissue) [ Time Frame: before and 90 min after cisplatin-fibrin application ]
  • PAI-1 and p21 markers for senescence in superficial chest wall tissue [ Time Frame: before and 90 min after cisplatin-fibrin application ]
  • in-treatment-field FFR freedom from recurrence = time to tumor progression by CT or PET-CT/MRI in the chest cavitiy where the IMP was applied [ Time Frame: up to 2 years (phase II) ]

Other Outcome Measures:
  • cisplatin concentration in pleural effusion by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection [ Time Frame: Pleural effusion collection: 0-48 h postoperative ]

Estimated Enrollment: 54
Study Start Date: November 2012
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intracavitary cisplatin-fibrin
single dose local intracavitary cisplatin-fibrin application after pleurectomy/decortication
Drug: intracavitary cisplatin-fibrin
single dose, local intracavitary application of cisplatin-fibrin after pleurectomy/decortication


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • Resectable MPM histologically confirmed (phase I: stage cT1-cT4 cN0-cN3 cM0-cM1 / phase II: stage cT1-cT3 cN0-cN1 cM0)
  • Only Phase II: Mediastinal staging (cytological or histological)
  • Only Phase II: Induction chemotherapy (3 cycles cisplatin or carboplatin combined with pemetrexed)
  • Patient qualifying for pleurectomy/decortication (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 ≥3.5 x G/L, neutrophils ≥1.5 x G/L, thrombocytes ≥100 x G/L; liver function: total bilirubin and LDH ≤1.5 ULN; AST, ALT, GGT, and AP ≤2.5 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%, aPTT within normal institutional limits, INR <=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 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, and/or restricted power of hearing until 4 kHz 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01644994

Contact: Isabelle Opitz, Professor MD +41 (0)44 255 11 11
Contact: Cordelia Bommeli, Study Coord.

University Hospital Zurich, Division of Thoracic Surgery Recruiting
Zurich, ZH, Switzerland, 8091
Contact: Isabelle Opitz, Prof MD    +41 44 255 11 11   
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
Swiss Accident Insurance Fund SUVA
Principal Investigator: Isabelle Opitz, Professor MD University Hospital Zurich, Division of Thoracic Surgery
  More Information

Responsible Party: University of Zurich Identifier: NCT01644994     History of Changes
Other Study ID Numbers: INFLuenCe - Meso
Study First Received: July 17, 2012
Last Updated: May 10, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antineoplastic Agents processed this record on May 22, 2017