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

NCT ID: NCT03136783

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-22
• Study Completion Date: 2019-09-22

Brief 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.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with stage IV melanoma

Group Type: OTHER

Development of the most specific physiologically relevant experimental patient models

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens Picardie

Amiens, Picardie, France

Site Status: RECRUITING

Countries

France

Central Contacts

Catherine LOK-CHARLES, PhD

Role: CONTACT

lok.catherine@chu-amiens.fr

+33322455841

Facility Contacts

Catherine LOK-CHARLES, PhD

Role: primary

lok.catherine@chu-amiens.fr

+33322455841

Other Identifiers

PI2016_843_0021

Identifier Type: -

Identifier Source: org_study_id