NICAM

Disease site: Melanoma

Treatment Modality: Other

Status: Open to recruitment

Acral melanoma (melanoma of palms of hands and sole of feet) accounts for approximately 5% of cutaneous melanomas whilst mucosal melanoma (commonest sites head & neck, anorectum and female genital tract) accounting for approximately 5% of non-cutaneous sites.

Approximately 120 patients per year will be diagnosed in the UK each year with advanced mucosal and acral melanoma of whom around 20% will have activated mutations in the receptor tyrosine kinase c-KIT. Given that there are no effective treatment options for these patients, the rationale exists to conduct a study in the UK using the targeted therapy Nilotinib.

The study objectives are to evaluate the efficacy of Nilotinib in advanced c-KIT mutated melanoma and to correlate c-KIT mutation, gene amplification and over-expression with response to treatment and survival.

NICAM is co-ordinated by the Clinical Trials & Statistics Unit at the Institute of Cancer Research (ICR-CTSU) and is supported by the NCRI melanoma Clinical Studies Group. Approximately 24 evaluable patients with the c-KIT mutation will be recruited from 9-10 specialist centres.