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2024-516189-12-00CompletedPhase 2

Role of Hydroxychloroquine in therapeutic strategy of Head and Neck cancer and Nonsmall cell lung cancer

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Jul 2024

Next steps

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
20 (actual)
First submitted
12 Jul 2024
Start date
1 Sept 2024
Lead sponsor
Ospedale San Raffaele S.r.l.
EU CT number
2024-516189-12-00
EudraCT number
2021-004189-37

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 20
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any regular concomitant medication which is contraindicated in the use together with HCQ

Other illness

  • 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

Lab values

  • 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.

Age

  • Ischemic heart disease (< 5 years)

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Ospedale San Raffaele S.r.l.MilanItalyCompleted

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