Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal (Epitopes-HPV01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01845779|
Recruitment Status : Recruiting
First Posted : May 3, 2013
Last Update Posted : August 5, 2016
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 or disease||Intervention/treatment||Phase|
|Metastatic Anal Canal Cancer Human Papillomavirus||Drug: DCF regimen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
|Experimental: patients in complete response||
Drug: DCF regimen
- presence and characterization of anti-HPV immune responses in patients in complete remission [ Time Frame: 3 months after sample ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845779
|Contact: Christophe BORG, Proffirstname.lastname@example.org|
|Contact: Marion JACQUINemail@example.com|
|Medical Oncology - University Hospital of Besançon||Recruiting|
|Besançon, France, 25000|
|Contact: Christophe BORG, Prof +3381615615 firstname.lastname@example.org|
|Contact: Marion JACQUIN email@example.com|
|Principal Investigator: Christophe BORG, Prof|
|Sub-Investigator: Jean-François BOSSET, Prof|
|Sub-Investigator: Thierry Nguyen, Doctor|