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

This study is currently recruiting participants. (see Contacts and Locations)
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
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 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
Neoplasms, Mesothelial
Adenoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014