MedPath

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

Phase 1
Active, not recruiting
Conditions
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).
Therapeutic area: Diseases [C] - Neoplasms [C04]
Registration Number
CTIS2024-516189-12-00
Lead Sponsor
Ospedale San Raffaele S.r.l.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Recruiting
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

Exclusion Criteria

Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4-Aminoquinolines4, Any regular concomitant medication which is contraindicated in the use together with HCQ, Diabetes type 1, Haematopoietic systems diseases, Myasthenia gravis, Psoriasis, Pregnant or breastfeeding women, Patients with Nasogastric or PEG feeding tube, Patients with deterioration of performance status beyond ECOG 2, Bradycardia or reduction in heart rhythm with arrhythmia, Uncorrected hypokalemia and/or hypomagnesemia, Ischemic heart disease (< 5 years), 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.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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