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

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03136783
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Other: Development of the most specific physiologically relevant experimental patient models	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy
• Actual Study Start Date: Mar 22, 2017
• Anticipated Primary Completion Date: Sep 22, 2019
• Anticipated Study Completion Date: Sep 22, 2019

Arms and Interventions

Arm

Intervention/Treatment

Other: Patient with stage IV melanoma

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

Outcome Measures

Primary Outcome Measures

1. Evaluating in vitro the response of tumor cells to different combinations of targeted therapy molecules [30 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens Picardie	Amiens	Picardie	France	80054

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT03136783
• Other Study ID Numbers: PI2016_843_0021
• First Posted: May 2, 2017
• Last Update Posted: May 2, 2017
• Last Verified: Apr 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Melanoma

Study Results

No Results Posted as of May 2, 2017