Role of Hydroxychloroquine in therapeutic strategy of Head and Neck cancer and Non-small cell lung cancer

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 20

Inclusion Criteria

Head and Neck Cancer group:
-Adults > or = 18 years of age.
-American Joint Committee on Cancer-defined clinical stage I, II, III, IV HN cancer that is deemed locally to be surgically resectable by a multidisciplinary clinical team and will receive radical surgery.
-Squamous Cell Carcinoma (SCC) of the oral cavity or larynx
-Treatment-naïve patients
-Eastern Cooperative Oncology Group (ECOG) performance status 0-2
-Patient capable giving informed consent
-QTc interval lower than 450 msec
-Measurable or evaluable disease defined by RECIST 1.1
-For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of drug administration.
-For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Non-small cell lung cancer group
-Adults > or = 18 years of age.
-American Joint Committee on Cancer-defined clinical stage IA, IB, IIA, IIB NSCLC that is deemed locally to be surgically resectable by a multidisciplinary clinical team and will receive radical surgery.
-Lung Squamous Cell Carcinoma or Adenocarcinoma.
-Treatment-naïve patients
-PDL1 > 50%
-Eastern Cooperative Oncology Group (ECOG) performance status 0-2
-Patient capable giving informed consent
-QTc interval lower than 450 msec
-Measurable or evaluable disease defined by RECIST 1.1
-For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of drug administration.
-For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

-Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4-Aminoquinolines4
-Bradycardia or reduction in heart rhythm with arrhythmia
-Uncorrected hypokalemia and/or hypomagnesemia
-Ischemic heart disease
-Congestive heart failure with use of diuretics
-Pre-existing retinopathy or maculopathy5
-Known Glucose-6-phosphate dehydrogenase deficiency (haemolytic anaemia, Favism)
-Known galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
-Known prolonged QT syndrome or current use of drugs with known prolongation of QT/QTc interval.
-Any regular concomitant medication which is contraindicated in the use together with HCQ
-Diabetes type 1
-Haematopoietic systems diseases
-Myasthenia gravis
-Pregnant or breastfeeding women
-Patients with Nasogastric or PEG feeding tube
-Patients with deterioration of performance status beyond ECOG 2

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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