The purpose of this study is to determine if topical imiquimod is effective in the pathological complete regression of lentigo maligna.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
250mg sachets to be applied at a start dose of 5 days a week. Dose will be adjusted using an algorithm according to tolerability.
Dr J Marsden
Queen Elizabeth Hospital, Birmingham, United Kingdom
Pathological complete regression (PCR) in the mapped biopsied and resected LM using 2 mm slices.
Time frame: Results available at 1-2 week post surgery follow up visit.
Clinical assessment of response after imiquimod treatment
The pathological response in the entire resected lesion will be compared with that predicted from clinical examination and biopsies taken before surgery, post imiquimod treatment. We will assess whether adequate surgical margins can be determined using clinical maps. It is essential to know the accuracy of the method of clinical assessment of response.
Time frame: Assessed at 12 week treatment visit and 1-2 week post surgery follow up
Clinical feasibility of imiquimod treatment
Number of reported local adverse reactions and systemic adverse reactions; adherence to treatment schedule and acceptability of imiquimod treatment.
Time frame: Tolerability will be assessed during treatment period of 12 weeks
Number of consultations with NHS staff during imiquimod treatment
Time frame: Assessed up to week 12 visit
Frequency of functional T cell responses recognising peptide epitopes in melanocyte differentiation and cancer-testis antigens.
Circulating immune responses to proteins expressed within melanoma will be measured using blood draws taken before imiquimod treatment and after completion of imiquimod therapy but before surgery. The demonstration of a circulating immune response would be an important finding that would strongly support the investigation of imiquimod as primary therapy for melanoma, even if coupled with subsequent surgery because of the potential for such an immune response to be preventative against recurrence or invasive disease.
Time frame: Assessed with baseline and 12 week visit samples.
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Measurement of hypothetical treatment preferences for surgery or imiquimod for LM using standard gamble technique.
Time frame: Questionnaire completed at 12 weeks post surgery (follow up visit)