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
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.
- Diseases
- Head and neck cancer, Lung cancer
- 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
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale San Raffaele S.r.l. | Milan | Italy | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.