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

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.


Sponsor: Institute of Cancer Research, United Kingdom

Current Primary Outcome: Proportion of participants with the c-KIT mutation who remain progression free at 6 months. [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • toxicity of treatment [ Time Frame: evaluated every 4 weeks whilst the patient is on treatment (on average estimated to be between 4 and 52 weeks) ]
    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 Study treatment will continue until the patient relapses or is withdrawn from study therapy (on average estimated to be between 4 and 52 weeks).
  • response at 12 weeks [ Time Frame: tumours measured at 12 weeks from start of treatment ]
    Lesions must be measured and or evaluated at 12 weeks in accordance with the Response evaluation criteria in solid tumours (RECIST)
  • overall survival [ Time Frame: Expected to be 6 - 12 months (Measured from commencement of treatment until time of death) ]


Original Secondary Outcome: Same as current

Information By: Institute of Cancer Research, United Kingdom

Dates:
Date Received: April 13, 2011
Date Started: December 2009
Date Completion:
Last Updated: May 18, 2012
Last Verified: April 2011