Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma
Conditions
Malignant Pleural Mesothelioma
Conditions: official terms
Mesothelioma
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: intracavitary cisplatin-fibrin
Type: Drug
Overall Status
Recruiting
Summary
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 IIa study for Malignant Pleural Mesothelioma patients by evaluation of the safety in a dose-escalating model.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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) 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 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 / 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
Location
University Hospital Zurich, Division of Thoracic Surgery
Zurich, ZH, Switzerland
Status: Recruiting
Contact: Isabelle Opitz, Prof MD - +41 44 255 11 11 - isabelle.schmitt-opitz@usz.ch
Start Date
November 2012
Completion Date
September 2016
Sponsors
University of Zurich
Source
University of Zurich
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page