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

Primary Purpose

Metastatic Anal Canal Cancer, Human Papillomavirus

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DCF regimen
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metastatic Anal Canal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Medical Oncology - University Hospital of Besançon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients in complete response

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

global survival
progression free survival

Full Information

First Posted
April 15, 2013
Last Updated
May 18, 2020
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT01845779
Brief Title
Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal
Acronym
Epitopes-HPV01
Official Title
Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Anal Canal Cancer, Human Papillomavirus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients in complete response
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DCF regimen
Primary Outcome Measure Information:
Title
presence and characterization of anti-HPV immune responses in patients in complete remission
Time Frame
3 months after sample
Secondary Outcome Measure Information:
Title
global survival
Time Frame
from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months
Title
progression free survival
Time Frame
from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Medical Oncology - University Hospital of Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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