A Trial Looking at Nilotinib to Treat Acral and Mucosal Melanoma Skin Cancer That Has Spread — NICAM  

Acral Lentiginous Malignant Melanoma Clinical Trial

Official title: A Phase II Trial of Nilotinib in the Treatment of Patients With c-KIT Mutated Advanced Acral and Mucosal Melanoma

Status Completed

Clinical Trial Summary

The aim of this study is to see if a drug called nilotinib (Tasigna®) is effective in the treatment of patients with a rare group of acral and mucosal melanomas that have a change (mutation) in a protein called cKIT. Nilotinib interferes with signalling inside cells with this mutation and it is believed that this may lead to shrinkage of tumours. Acral melanomas are found on the palms and soles and mucosal melanomas start inside body cavities rather than on the skin.

Clinical Trial Description

NICAM has a two step consent process. Patients diagnosed with advanced acral or mucosal melanoma first consent for study registration and undergo screening tests including testing samples of melanoma tissue for the c-KIT mutation.

Following confirmation of the c-KIT mutation, patients are asked to consent to study entry with continuation of screening. Eligible patients then enter the study and commence taking nilotinib tablets twice a day for as long as clinical benefit is maintained. ;

Related Conditions & MeSH terms

• Acral Lentiginous Malignant Melanoma
• Melanoma
• Mucosal Lentiginous Melanoma

• NCT number: NCT01395121
• Study type: Interventional
• Source: Institute of Cancer Research, United Kingdom
• Status: Completed
• Phase: Phase 2
• Start date: December 2009
• Completion date: December 12, 2016