Human Papillomavirus Clinical Trial
— Epitopes-HPV01Official title:
Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal
Verified date | May 2020 |
Source | Centre Hospitalier Universitaire de Besancon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | December 31, 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | Medical Oncology - University Hospital of Besançon | Besançon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Besancon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | presence and characterization of anti-HPV immune responses in patients in complete remission | 3 months after sample | ||
Secondary | global survival | from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months | ||
Secondary | progression free survival | from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months |
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