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

Human Papillomavirus Clinical Trial

— Epitopes-HPV01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845779
• Other study ID #: Epitope-HPV01
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 31, 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Human Papillomavirus
• Metastatic Anal Canal Cancer
• Neoplasm Metastasis

Intervention

Drug:
• DCF regimen

Locations

Country	Name	City	State
France	Medical Oncology - University Hospital of Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence and characterization of anti-HPV immune responses in patients in complete remission		3 months after sample
Secondary	global survival		from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months
Secondary	progression free survival		from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months