Evaluation of Immune Response Against Human Papillomaviru... | NCT01845779

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

NCT01845779

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

May 20, 2020Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Metastatic Anal Canal Cancer
Human Papillomavirus

Interventions

DCF regimen

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012Actual

Primary Completion Date

Jul 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Apr 15, 2013

First Submission Date that Met QC Criteria

May 2, 2013

First Posted Date

May 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2020

Last Update Posted Date

May 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Label	Type	Description	Intervention Names
patients in complete response	Experimental		Drug: DCF regimen

Name	Type	Description	Arm Group Labels	Other Names
DCF regimen	Drug		patients in complete response

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Oncology - University Hospital of Besançon		Besançon		25000	France

Condition Browse Module

MeSH Terms

ID	Term
C563020	Anal Canal Carcinoma

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided