Safety and Efficacy of TTFields (150 kHz) Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR)

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a prospective, single arm, non-randomized, open label phase II trial, designed to study the safety and efficacy of a medical device, the NovoTTF-100L concomitant with Pemetrexed and cisplatin or carboplatin in Malignant Pleural Mesothelioma patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovoCure Ltd.
• Treatments: Carboplatin; Cisplatin; Pemetrexed

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)