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NCT Number: NCT01845779

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

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.

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Key information

Conditions

Metastatic Anal Canal Cancer Anal Canal Carcinoma Human Papillomavirus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Oncology - University Hospital of Besançon

Besançon, 25000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DCF regimen

Drug

Primary outcomes

  1. presence and characterization of anti-HPV immune responses in patients in complete remission

    Time frame: 3 months after sample

Secondary outcomes

  1. global survival

    Time frame: from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months

  2. progression free survival

    Time frame: from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: Epitopes-HPV01

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
May 3, 2013
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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