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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Pleural Mesothelioma

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

number of participants with adverse events

Outcome Time Frame:

during 4 weeks after surgery with local cisplatin-fibrin application

Safety Issue:

Yes

Principal Investigator

Isabelle Opitz, Professor MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Zurich, Division of Thoracic Surgery

Authority:

Switzerland: Swissmedic

Study ID:

INFLuenCe - Meso

NCT ID:

NCT01644994

Start Date:

November 2012

Completion Date:

September 2016

Related Keywords:

  • Malignant Pleural Mesothelioma
  • Mesothelioma

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