Safety, toxicity and immunogenicity of HPV16 E7 DNA vaccination in HPV16+ vulvar intraepithelial neoplasia grade III: a phase I study. - SEVE

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。

•* Age above 18 years
•* Willing and able to undergo the planned study procedures
•* Written informed consent
•* Histologically proven visible VINIII lesion (last histology <=3 months prior to enrolment)
•* HPV16+ VINIII lesion (to be determined on archival tumour tissue (<=10 years old); if that is not available a biopsy will be required)
•* No indication of an active infectious disease
•* No history of autoimmune disease or systemic undercurrent disease which might affect immunocompetence
•* Adequate bonemarrow, renal function and liver function

•* Prior treatment with anti-HPV agents
•* Participation in a study with another investigational drug within 30 days prior to the enrolment in this study
•* Severe cardiac, respiratory or metabolic disease
•* Use of steroids or other immunosuppressive drugs
•* Use of oral anticoagulant drugs
•* History of a malignancy except curatively treated low-stage tumour
•* Severe infections requiring antibiotic
•* Any treatment for the VINIII lesion within 6 weeks prior to enrolment
•* Lactation or pregnancy (if applicable)
•* Not willing to take adequate contraceptive measures (if applicable)

发起方

Antoni van Leeuwenhoek Ziekenhuis