EUCTR2021-004189-37-IT
Active, not recruiting
Phase 1
Role of Hydroxychloroquine in therapeutic strategy of Head and Neck cancer and Non-small cell lung cancer - HCQHNLcancer
OSPEDALE SAN RAFFAELE0 sites20 target enrollmentAugust 31, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- OSPEDALE SAN RAFFAELE
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
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.
Exclusion Criteria
- •\-Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4\-Aminoquinolines4
- •\-Bradycardia or reduction in heart rhythm with arrhythmia
- •\-Uncorrected hypokalemia and/or hypomagnesemia
- •\-Ischemic heart disease
- •\-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.
- •\-Any regular concomitant medication which is contraindicated in the use together with HCQ
Outcomes
Primary Outcomes
Not specified
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