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

Brief 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 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.

Tracking Information
First Received DateJuly 17, 2012
Last Changed DateMay 10, 2016
Start DateNovember 2012
Anticipated Primary Completion DateAugust 2020
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)]

Descriptive Information
PhasePhase 1/Phase 2
Study TypeInterventional
Condition
  • Malignant Pleural Mesothelioma
Intervention
  • Drug: intracavitary cisplatin-fibrin
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment54
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Isabelle Opitz, Professor MD
Email: isabelle.schmitt-opitz@usz.ch
Phone: +41 (0)44 255 11 11
Eligibility 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

- 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

Administrative Information
NCTIDNCT01644994
Responsible Party,
SponsorUniversity of Zurich
Verification DateMay 2016
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