Clinical trial NCT02397928 (phase 2, status: completed)
Conditions: malignant pleural mesothelioma
ICD codes: C45.9, C45.0, C45.1, C45.2, C45.7
Drugs: pemetrexed, cisplatin or carboplatin
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H], [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
Eligibility criteria:

        Inclusion Criteria:

          1. Pathological or histological evidence of mesothelioma

          2. ≥ 18 years of age

          3. Not candidate for curative treatment (surgery or radiotherapy)

          4. At least 4 weeks since major surgery

          5. At least one measurable or evaluable lesion according to modified RECIST Criteria

          6. ECOG Performance Status of 0-1

          7. Life expectancy of at least 3 months

          8. Participants of childbearing age must use effective contraception as indicated by the
             investigator

          9. All subjects must sign written informed consent.

         10. Able to operate the NovoTTF-100L System independently or with the help of a caregiver

        Exclusion Criteria:

          1. Patient candidate for surgery or radiotherapy with curative intent

          2. Previous chemotherapy or radiation

          3. Prior malignancy requiring anti-tumor treatment (apart from in-situ cervical cancer,
             in situ breast cancer, non-melanomatous skin cancers, or any malignancy for which
             treatment was received and there is no evidence of disease for at least 5 years) or
             concurrent malignancy

          4. Significant co-morbidities within 4 weeks prior to enrollment, resulting in the
             following laboratory findings:

               1. Significant liver function impairment:

                    -  AST or ALT > 3 times the upper limit of normal

                    -  Total bilirubin ≥ 1.5 times upper limit of normal

               2. Significant renal impairment (serum creatinine > 1.7 mg/dL)

               3. Coagulopathy (as evidenced by PT or APTT >1.5 times control in subjects not
                  undergoing anticoagulation)

               4. Thrombocytopenia (platelet count < 100 x 10^3/μL)

               5. Neutropenia (absolute neutrophil count < 1.5 x 10^3/μL)

               6. Anemia (Hb < 10 g/dL)

               7. Severe acute infection

          5. Significant comorbidity which is expected to affect patient's prognosis or ability to
             receive the combined therapy:

               1. History of significant cardiovascular disease unless the disease is well
                  controlled.

                  Significant cardiac disease includes second/third degree heart block; significant
                  ischemic heart disease; poorly controlled hypertension; congestive heart failure
                  of the New York Heart Association (NYHA) Class II or worse (slight limitation of
                  physical activity; comfortable at rest, but ordinary activity results in fatigue,
                  palpitation or dyspnea)

               2. History of arrhythmia that is symptomatic or requires treatment. Patients with
                  atrial fibrillation or flutter controlled by medication are not excluded from
                  participation in the trial

               3. Active infection or any serious underlying medical condition that would impair
                  the ability of the patient to receive protocol therapy

               4. History of any psychiatric condition that might impair the patient's ability to
                  understand or comply with the requirements of the study or to provide consent

          6. Untreated brain metastases. Asymptomatic, pretreated brain metastases not requiring
             steroids are allowed

          7. Implanted pacemaker, defibrillator or other electrical medical devices

          8. Known allergies to medical adhesives or hydrogel

          9. Pregnant or breast feeding (all patients of childbearing potential must use effective
             contraception method during the entire period of the study based on the recommendation
             of the investigator or a gynecologist)