Effect of Topical Imiquimod on Lentigo Maligna (LIMIT-1)
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ClinicalTrials.gov Identifier: NCT01161888
Recruitment Status :
First Posted : July 14, 2010
Last Update Posted : June 20, 2012
Department of Health, United Kingdom
Information provided by (Responsible Party):
Jerry Marsden, University Hospital Birmingham NHS Foundation Trust
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. ]
Secondary Outcome Measures :
Clinical assessment of response after imiquimod treatment [ Time Frame: Assessed at 12 week treatment visit and 1-2 week post surgery follow up ]
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.
Clinical feasibility of imiquimod treatment [ Time Frame: Tolerability will be assessed during treatment period of 12 weeks ]
Number of reported local adverse reactions and systemic adverse reactions; adherence to treatment schedule and acceptability of imiquimod treatment.
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. [ Time Frame: Assessed with baseline and 12 week visit samples. ]
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.
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) ]
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Layout table for eligibility information
Ages Eligible for Study:
45 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Clinical diagnosis of lentigo maligna (LM) (acquired pigmented macule present for more than 12 months with no change in skin surface texture or contour, no palpability, diameter >10 mm, sited on the head or neck). The lower anatomical limit is the root of the neck - a line joining the medial end of the clavicles with the medial insertion of trapezius.
Histological findings consistent with LM (increased numbers of atypical melanocytes confined to the epidermis, sun damaged skin) in one or more 4mm punch biopsies(s) from the darkest area, reported by a pathologist with expertise in the diagnosis of melanocytic lesions, and part of a recognised NHS skin cancer Multi-Disciplinary Team.
The upper limit of the lesion is not defined by size, but it must be suitable for complete surgical excision using a 5 mm lateral margin.
The outline of the lesion must be easily defined visually in daylight around its entire circumference.
Patient fit enough and willing to undergo surgery as required by the protocol.
Clinical or histological evidence of invasive melanoma including any palpability of the lesion, or clinical and/or histological evidence of regression or dermal invasion
Aged less than 45 years
Recurrent LM - the index lesion must not have been previously treated
Life expectancy of less than 12 months
Other skin lesions which may compromise the ability to complete this study, such as co-existing or adjacent melanoma or non-melanoma skin cancer. Co-existing adjacent actinic keratoses would not exclude the patient from the study
Women of childbearing potential, who are pregnant, plan to become pregnant during their study participation or breastfeeding.
Unable to give informed consent.
Hypersensitivity to imiquimod or to any of the excipients (methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetyl alcohol and stearyl alcohol).