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

NCT03136783 | Unknown

• 1 other identifier: PI2016_843_0021
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Evaluating in vitro the response of tumor cells to different combinations of targeted therapy molecules

  30 months

Study Arms (1)

Patient with stage IV melanoma

OTHER

Other: Development of the most specific physiologically relevant experimental patient models

Interventions

Development of the most specific physiologically relevant experimental patient models 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

Patient with stage IV melanoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major Patients,
• patients with melanoma (stage IV) with cutaneous metastases,
• seronegative HIV, HBV, HCV, HTLV1.

You may not qualify if:

• Absence of cutaneous metastasis or in transit
• HIV or HBV or HCV or HTLV1 seropositivity
• Patient minor, patient under guardianship or curatorship

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Catherine LOK-CHARLES, PhD

CONTACT

+33322455841; lok.catherine@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 2, 2017
• Study Start: March 22, 2017
• Primary Completion: September 22, 2019
• Study Completion: September 22, 2019
• Last Updated: May 2, 2017

Record last verified: 2017-04

Locations

FR (1)