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

Ospedale San Raffaele S.r.l.0 sites20 target enrollmentJuly 12, 2024

ConditionsPatients 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]

Overview

Phase: Phase 1
Intervention: Not specified
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).
Sponsor: Ospedale San Raffaele S.r.l.
Enrollment: 20
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 12, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Ospedale San Raffaele S.r.l.

Eligibility 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

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.