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

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ClinicalTrials.gov Identifier: NCT01845779
Recruitment Status : Recruiting
First Posted : May 3, 2013
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

April 15, 2013
May 3, 2013
August 5, 2016
September 2012
January 2020   (Final data collection date for primary outcome measure)
presence and characterization of anti-HPV immune responses in patients in complete remission [ Time Frame: 3 months after sample ]
Same as current
Complete list of historical versions of study NCT01845779 on ClinicalTrials.gov Archive Site
  • global survival [ Time Frame: from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months ]
  • progression free survival [ Time Frame: from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months ]
Same as current
Not Provided
Not Provided
 
Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal
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.

Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
  • Metastatic Anal Canal Cancer
  • Human Papillomavirus
Drug: DCF regimen
Experimental: patients in complete response
Intervention: Drug: DCF regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4
Same as current
January 2020
January 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Christophe BORG, Prof +3381615615 christophe.borg@efs.sante.fr
Contact: Marion JACQUIN m1jacquin@chu-besancon.fr
France
 
 
NCT01845779
Epitope-HPV01
No
Not Provided
Not Provided
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Universitaire de Besancon
Not Provided
Not Provided
Centre Hospitalier Universitaire de Besancon
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP