Phase I clinical study of vascular targeting fluorescent cationic liposomes in head and neck cancer
| Autor: | Barbara Wollenberg, Uwe Michaelis, Martin E. Eichhorn, Sebastian Strieth, Christoph Dunau, Hannelore Ledderose, Donata Strelczyk, Uta Tschiesner, Marc Dellian, Ruth Knuechel, Kristina Kolbow |
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| Rok vydání: | 2012 |
| Předmět: |
Male
Pathology medicine.medical_specialty Biopsy Urology Phases of clinical research Drug Delivery Systems medicine Humans Cationic liposome Prospective Studies Infusions Intravenous Prospective cohort study Microvessel Aged Fluorescent Dyes Neoplasm Staging Dose-Response Relationship Drug medicine.diagnostic_test Rhodamines business.industry Head and neck cancer Histology General Medicine Middle Aged medicine.disease Head and neck squamous-cell carcinoma Otorhinolaryngologic Neoplasms Microscopy Fluorescence Otorhinolaryngology Liposomes Microvessels Carcinoma Squamous Cell Female business |
| Zdroj: | European Archives of Oto-Rhino-Laryngology. 270:1481-1487 |
| ISSN: | 1434-4726 0937-4477 |
| DOI: | 10.1007/s00405-012-2185-2 |
| Popis: | The aim of this first-time-in-human non-randomized dose-escalating prospective phase I clinical trial was to analyze safety of two doses of fluorescent rhodamine-labeled cationic liposomes (LDF01) in head and neck squamous cell carcinoma (HNSCC). Patients had resectable UICC stadium I-IV A HNSCCs. LDF01 was administered before tumor resection under general anesthesia as an intravenous infusion with effective lipid doses of 0.5 or 2 mg/kg b.w., respectively. In addition to clinical monitoring for safety assessment, tumor biopsies were taken during the surgical procedure for fluorescence histological analysis. Eight patients were assigned to the two dose groups. During safety follow-up no clinically relevant adverse events occurred. Fluorescence histology revealed some evidence of favorable selectivity of LDF01 for tumor microvessels in the high-dose group. LDF01 is safe applied as infusion at both tested dose levels. Furthermore, LDF01 can be detected in the vicinity of tumor cells and could be assigned to the microvessel target in individual HNSSC cases. Detailed analysis of targeting properties of LDF01 has to be performed in upcoming clinical phase II trials. |
| Databáze: | OpenAIRE |
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