Effect of Topical Imiquimod on Lentigo Maligna (LIMIT-1)
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|ClinicalTrials.gov Identifier: NCT01161888|
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : June 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Lentigo Maligna||Drug: Imiquimod||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Topical Imiquimod on Lentigo Maligna|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
- Drug: Imiquimod
250mg sachets to be applied at a start dose of 5 days a week. Dose will be adjusted using an algorithm according to tolerability.Other Name: Aldara 5% cream
- 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 [ 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161888
|Dr J Marsden|
|Queen Elizabeth Hospital, Birmingham, United Kingdom, B15 2TH|
|Principal Investigator:||Jerry Marsden, Dr||University Hospitals Birmingham NHS Foundation Trust|