Patients affected by Resectable Head and Neck (HN) cancer (only Squamous Cell Carcinoma of the oral cavity or larynx), or Resectable Non-small cell lung cancer (NSCLC, only Lung Squamous Cell Carcinoma or Adenocarcinoma). MedDRA version: 20.0 Level: LLT Classification code 10078181 Term: Laryngeal squamous cell carcinoma stage 0 System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10030964 Term: O
Conditions
Interventions
Trade Name: PLAQUENIL - 200 MG COMPRESSE RIVESTITE 30 COMPRESSE
Product Name: Idrossiclorochina Solfato
Product Code: [Idrossiclorochina Solfato]
Pharmaceutical Form: Coated tablet
INN or Proposed I
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the biological effect of Hydroxychloroquine and its anticancer activity in patients with resectable Head and Neck cancer and Non-small cell lung cancer;Secondary Objective: To assess R0 resection rates.;Primary end point(s): Immunohistochemical studies will be performed for known autophagic and immunological markers (CD3, CD8, CD163, p53, p62, LC3) with quantification of positivity / total cells, intensity, expression pattern.;Timepoint(s) of evaluation of this end point: Histopathological analysis at day 0 (diagnostic biopsy) and at day 16 (tumor specimen) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Identification and quantification of margins’ resection status (R0, R1, R2);Timepoint(s) of evaluation of this end point: Intraoperative assessment and histopathological analysis at day 16 (tumor specimen) | — |
Countries
Italy
Contacts
Public ContactClinical Trial Center
Ospedale San Raffaele
Outcome results
None listed