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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
nilotinib 400 mgs orally twice daily until disease progression or withdrawal from treatment
Royal Marsden NHS Foundation Trust
London, United Kingdom
Proportion of participants with the c-KIT mutation who remain progression free at 6 months.
Progression free survival times will be measured from the date of enrolment into the treatment phase until the first date (following start of treatment) of either death or confirmed progressive disease according to RECIST.
Time frame: 6 months
toxicity of treatment
Treatment related toxicity will be assessed at each clinic visit approximately every 4 weeks whilst the patient continues on study treatment. Study treatment will continue until the patient relapses or is withdrawn from study therapy (on average estimated to be between 4 and 52 weeks).
Time frame: evaluated every 4 weeks whilst the patient is on treatment (on average estimated to be between 4 and 52 weeks)
response at 12 weeks
Lesions must be measured and or evaluated at 12 weeks in accordance with the Response evaluation criteria in solid tumours (RECIST)
Time frame: tumours measured at 12 weeks from start of treatment
overall survival
Time frame: Expected to be 6 - 12 months (Measured from commencement of treatment until time of death)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.