Middle ear thiosulfate-gel protection against cisplatin-induced hearing loss in patients carrying a single nucleotide polymorphism in the TPMT, COMT or LRP2 gene - N12MTG

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1. Histological or cytological proof of advanced cancer for which cisplatin treatment at a minimal dose of 75 mg/m2 per 21 days is considered of benefit; for example non-small cell lung cancer; patients with a head and neck malignancy of the oropharynx, hypofarynx, oral cavity and larynx with blue or brown eyes.
•2. Age * 18 years;
•3. Able and willing to give written informed consent;
•4. WHO performance status of 0, 1 or 2;
•5. No relevant otological history; (presbyacusis, conductive hearing loss, air-bone gap (ABG), complaints of tinnitus or vertigo, ototoxic co-medication (see appendix VI), chronic middle ear infections, trauma, operations, or hearing aid) ,
•6. Able and willing to undergo blood sampling for PK analysis and genetic analysis for specific SNPs;
•7. Minimal acceptable safety laboratory values;
•a. ANC of * 1.5 x 109 /L
•b. Platelet count of * 100 x 109 /L
•c. Hepatic function as defined by serum bilirubin * 1.5 x ULN, ALAT and ASAT * 2.5 x ULN or *5 x ULN in case of liver metastases
•d. Renal function as defined by serum creatinine * 2.5 x ULN or creatinine clearance * 60 ml/min (by Cockcroft-Gault formula).
•8. Negative pregnancy test (urine/serum) for female patients with childbearing potential;
•9. Combined treatment of cisplatin with other cytostatic, cytotoxic or radiation therapy according to local treatment guidelines is permitted. However, radiation therapy to the head and neck region is excluded.

•1. Any treatment with investigational drugs or other antineoplastic therapy within 21 days prior to receiving the first dose of investigational treatment;
•2. Patients who have had previous systemic treatment with cisplatin or oxaliplatin; (HIPEC and other local non systemic therapy are allowed)
•3. Known hypersensitivity to STS containing HYA gel formulation;
•4. Patients with symptomatic brain metastases, carcinomatous leptomeningitis at start;
•5. Woman who are pregnant or breast feeding;
•6. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
•7. Patients with a known history of hepatitis B or C;
•8. Patients with a head and neck malignancy other than; oropharynx, hypopharynx, oral cavity and larynx or patients with a head and neck malignancy green eyes.
•9. Any condition that would, in the investigator judgement contraindicate the patients participation in the clinical study due to safety concerns or compliance with clinical study procedures

发起方

Antoni van Leeuwenhoek Ziekenhuis