New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy

Melanoma (Skin) Clinical Trial

— SkinTher  

Official title:

New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03136783
• Other study ID #: PI2016_843_0021
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2017
• Last updated: April 28, 2017
• Start date: March 22, 2017
• Est. completion date: September 22, 2019

Study information

• Verified date: April 2017
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Catherine LOK-CHARLES, PhD
• Phone: +33322455841
• Email: lok.catherine[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The choice of treatment of patients with metastatic melanoma depends on the status of B-RAF of the tumor: in the absence of mutation, treatment with immunotherapy (currently anti-PD1) is proposed in the first line; When B-RAF is mutated, treatment with targeted therapies is retained: B-RAF and MEK inhibitors are prescribed in combination (vemurafenib + cobimetinib or dabrafenib + trametinib).

Patient response rates for targeted therapies range from 50 to 60%, and the occurrence of sometimes severe side effects is not predictable. There are currently no predictive biomarkers of patients' response to targeted therapy molecules. The in vitro evaluation of the intrinsic sensitivity of the cells of patients to different combinations of targeted therapy molecules would make it possible to propose the best therapeutic combinations. The cutaneous metastases are chosen in the model because of easy access to collect tumor tissue.

The most relevant in vitro models for mimicking cutaneous melanoma metastases are explant cultures and human skin equivalents.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: September 22, 2019
• Est. primary completion date: September 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major Patients,

• patients with melanoma (stage IV) with cutaneous metastases,

• seronegative HIV, HBV, HCV, HTLV1.

Exclusion Criteria:

• Absence of cutaneous metastasis or in transit

• HIV or HBV or HCV or HTLV1 seropositivity

• Patient minor, patient under guardianship or curatorship

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Other:
• Development of the most specific physiologically relevant experimental patient models
Development of the most specific physiologically relevant experimental patient models: organotypic culture of biopsies, reconstituted skin (equivalents of dermis with melanoma, dermis equivalents and epidermis with melanoma), and in vitro evaluation The response of tumor cells to different combinations of targeted therapy molecules

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating in vitro the response of tumor cells to different combinations of targeted therapy molecules		30 months