Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01644994 : Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Eligibility
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 ?mol/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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01644994      |      Link to official Clinicaltrials.gov listing
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