- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01845779
Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal (Epitopes-HPV01)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Besançon, France, 25000
- Medical Oncology - University Hospital of Besançon
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patients in complete response
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
presence and characterization of anti-HPV immune responses in patients in complete remission
Time Frame: 3 months after sample
|
3 months after sample
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
global survival
Time Frame: from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months
|
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
|
from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Epitope-HPV01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Anal Canal Cancer
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ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)Active, not recruitingAnal Squamous Cell Carcinoma | Anal Basaloid Carcinoma | Anal Canal Cloacogenic Carcinoma | Metastatic Anal Canal Carcinoma | Recurrent Anal Canal Carcinoma | Stage IIIB Anal Canal Cancer | Stage IV Anal Canal CancerUnited States
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