Intracavitary Cisplatin-Fibrin Localized Chemotherapy After Pleurectomy/Decortication for Malignant Pleural Mesothelioma

This study is currently recruiting participants.
Verified April 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01644994
First received: July 17, 2012
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

The aim is to introduce a new therapeutic method of intracavitary chemotherapy (cisplatin) combined with a fibrin carrier (Vivostat®) after pleurectomy/decortication in a phase I and IIa study for Malignant Pleural Mesothelioma patients by evaluation of the safety in a dose-escalating model.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PhaseI Dose-Escalation /PhaseIIa Monocentric Open Trial for Evaluation of Safety of Intracavitary Cisplatin-Fibrin Localized Chemotherapy After Pleurectomy/Decortication 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 ] [ Designated as safety issue: Yes ]
  • local cisplatin concentration in the superficial chest wall tissue (only Phase I) by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection [ Time Frame: 90 min after application ] [ Designated as safety issue: Yes ]
  • safety blood parameters (hematology and clinical chemistry) [ Time Frame: baseline and 1, 2, 3, 4, 5, 7, 10, 14 days postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • time to tumor progression by CT or PET-CT/MRI [ Time Frame: 4, 16 weeks, then every 4 months up to 5 years ] [ Designated as safety issue: No ]
  • change from baseline in SF-36 quality of life questionnaire [ Time Frame: 0, 4, 8 weeks ] [ Designated as safety issue: No ]
  • change from baseline in EORTC Lung Cancer Questionnaire QLQ-C15/LC13 [ Time Frame: 0, 4, 8 weeks ] [ Designated as safety issue: No ]
  • cisplatin concentration in blood serum by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection [ Time Frame: baseline before treatment with cisplatin-fibrin as well as at 0, 2, 6, 10, 24, 48, and 120 h postoperative ] [ Designated as safety issue: No ]
    pharmacokinetics

  • cisplatin concentration in urine by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection [ Time Frame: collection of first 48h, day 14 postoperative ] [ Designated as safety issue: No ]
    pharmacokinetics

  • TUNEL assay (markers for apoptosis in superficial chest wall tissue) [ Time Frame: before and 90 min after cisplatin-fibrin application ] [ Designated as safety issue: No ]
  • PAI-1 and p21 markers for senescence in superficial chest wall tissue [ Time Frame: before and 90 min after cisplatin-fibrin application ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: November 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (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: cisplatin - fibrin
single dose, local intracavitary application of cisplatin-fibrin after pleurectomy/decortication

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • MPM histologically confirmed (stage cT1-cT4 cN0-cN3 cM0-cM1)
  • Patient qualifying for pleurectomy/decortication (P/D) for resection of MPM, which has to be assessed during a multidisciplinary tumor board including a thoracic surgeon
  • Patient must have normal organ and bone marrow function as defined: normal hematologic function (hemoglobin >=100 g/L, WBC >=3.5 x G/L, neutrophils >=1.5 x G/L, thrombocytes >=100 x G/L), total bilirubin and liver function tests within normal institutional limits, creatinine within normal institutional limits or creatinine clearance >=60 ml/min/1.73m2 for patients with creatinine concentrations above institutional normal limits.
  • Patient must have an appropriate blood coagulation for P/D (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 pleurectomy
  • Patient with uncontrolled intercurrent illnesses including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the operative procedure of P/D or compliance with study requirements
  • Tinnitus and/or restricted power of hearing (especially in the upper frequency range) confirmed by audiometry
  • Known alcohol and/or drug abuse at the time of screening
  • Pregnant or lactating woman
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644994

Contacts
Contact: Isabelle Opitz, Professor, MD +41 (0)44 255 11 11 isabelle.schmitt-opitz@usz.ch
Contact: Cordelia Bommeli, Study Coordinator cordelia.bommeli@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Thoracic Surgery Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Isabelle Opitz, Professor MD University Hospital Zurich, Division of Thoracic Surgery
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01644994     History of Changes
Other Study ID Numbers: INFLuenCe - Meso
Study First Received: July 17, 2012
Last Updated: April 4, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014