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

NCT ID: NCT01845779

Last Updated: 2020-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Anal Canal Cancer Human Papillomavirus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patients in complete response

Group Type EXPERIMENTAL

DCF regimen

Intervention Type DRUG

Interventions

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DCF regimen

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical Oncology - University Hospital of Besançon

Besançon, , France

Site Status

Countries

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France

Other Identifiers

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Epitope-HPV01

Identifier Type: -

Identifier Source: org_study_id

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