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

This study is currently recruiting participants.
Verified April 2013 by Centre Hospitalier Universitaire de Besancon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01845779
First received: April 15, 2013
Last updated: May 2, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Metastatic Anal Canal Cancer
Human Papillomavirus
Drug: DCF regimen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • presence and characterization of anti-HPV immune responses in patients in complete remission [ Time Frame: 3 months after sample ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • global survival [ Time Frame: from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 4
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patients in complete response Drug: DCF regimen

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01845779

Contacts
Contact: Christophe BORG, Prof +3381615615 christophe.borg@efs.sante.fr
Contact: Marion JACQUIN m1jacquin@chu-besancon.fr

Locations
France
Medical Oncology - University Hospital of Besançon Recruiting
Besançon, France, 25000
Contact: Christophe BORG, Prof    +3381615615    christophe.borg@efs.sante.fr   
Contact: Marion JACQUIN       m1jacquin@chu-besancon.fr   
Principal Investigator: Christophe BORG, Prof         
Sub-Investigator: Jean-François BOSSET, Prof         
Sub-Investigator: Thierry Nguyen, Doctor         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01845779     History of Changes
Other Study ID Numbers: Epitope-HPV01
Study First Received: April 15, 2013
Last Updated: May 2, 2013
Health Authority: France: Committee for the Protection of Person
France: French Health Products Safety Agency

Additional relevant MeSH terms:
Neoplasm Metastasis
Anus Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 17, 2014