Role of Hydroxychloroquine in therapeutic strategy of Head and Neck cancer and Nonsmall cell lung cancer
Key facts
- Where
- Milan, OlaszországSee the site
- Phase
- 2. fázis
Where in Olaszország
- Ospedale San Raffaele S.r.l.Milan, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ospedale San Raffaele S.r.l.
- Trial code
- EU 2024-516189-12-00
- Record updated
- 2024. július 29.
- Original description
To determine the biological effect of Hydroxychloroquine on tumor cells and tumor microenvironment in patients with resectable Head and Neck cancer and Non-small cell lung cancerRead full original descriptionShow less
Role of Hydroxychloroquine in therapeutic strategy of Head and Neck cancer and Non-small cell lung cancer
To determine the biological effect of Hydroxychloroquine on tumor cells and tumor microenvironment in patients with resectable Head and Neck cancer and Non-small cell lung cancer
Inclusion: 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.
Exclusion: Any regular concomitant medication which is contraindicated in the use together with HCQ; Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4-Aminoquinolines4; Diabetes type 1; Haematopoietic systems diseases; Bradycardia or reduction in heart rhythm with arrhythmia; Congestive heart failure with use of diuretics; 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; Ischemic heart disease (< 5 years); Myasthenia gravis; Psoriasis; Pregnant or breastfeeding women; Patients with Nasogastric or PEG feeding tube; Patients with deterioration of performance status beyond ECOG 2; Uncorrected hypokalemia and/or hypomagnesemia; Pre-existing retinopathy or maculopathy5.