Clinical Trials /

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

NCT01845779

Description:

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.

Related Conditions:
  • Anal Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal
  • Official Title: Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal

Clinical Trial IDs

  • ORG STUDY ID: Epitope-HPV01
  • NCT ID: NCT01845779

Conditions

  • Metastatic Anal Canal Cancer
  • Human Papillomavirus

Interventions

DrugSynonymsArms
DCF regimenpatients in complete response

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.

Trial Arms

NameTypeDescriptionInterventions
patients in complete responseExperimental
  • DCF regimen

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:presence and characterization of anti-HPV immune responses in patients in complete remission
Time Frame:3 months after sample
Safety Issue:
Description:

Secondary Outcome Measures

Measure:global survival
Time Frame:from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months
Safety Issue:
Description:
Measure:progression free survival
Time Frame:from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months
Safety Issue:
Description:

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Centre Hospitalier Universitaire de Besancon

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