Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal (Epitopes-HPV01)

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Metastatic Anal Canal Cancer

Human Papillomavirus

Treatments

Drug: DCF regimen

Study type

Interventional

Funder types

Other

Identifiers

NCT01845779

Epitope-HPV01

Details and patient eligibility

About

Complete response is a rare event in metastatic anal cancer in the case of unresectable recurrence after radiochemotherapy.

In the University Hospital Center of Besançon, 8 patients with metastatic anal cancer were treated between 2005 and 2008 by 6 cycles of chemotherapy including taxane: DCF (Docetaxel, Cisplatin and 5-Fluorouracil.

In more than 90% of cases, anal cancers are related to Human Papilloma Virus (HPV) infection, that is the case of this patients for which HPV16 (human papillomavirus type 16) genotype was identified within the tumor samples.

The hypothesis is that an anti-HPV response immune could be generated by chemotherapy with DCF and contributed to the elimination of the tumour cells and to the increase of complete responses. The aim to this study is to analyze immune response against HPV in this patients in complete response.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

ECOG performance status ≤ 1
patient with metastatic anal cancer HPV+
presence of a measurable target lesion according to radiological criteria (Recist V1.1)
patient with more than 12 months of complete remission of metastatic anal cancer according to radiological criteria (Recist V1.1)after treatment by DCF regimen (Docetaxel, Cisplatin and 5-Fluorouracil)

Exclusion criteria

pregnancy or lactation
patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.