Effect of Topical Imiquimod on Lentigo Maligna (LIMIT-1)
This study has been completed.
Department of Health, United Kingdom
Information provided by (Responsible Party):
Jerry Marsden, University Hospital Birmingham NHS Foundation Trust
First received: June 24, 2010
Last updated: June 18, 2012
Last verified: May 2010
The purpose of this study is to determine if topical imiquimod is effective in the pathological complete regression of lentigo maligna.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Topical Imiquimod on Lentigo Maligna|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by University Hospital Birmingham NHS Foundation Trust:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01161888
|Dr J Marsden|
|Queen Elizabeth Hospital, Birmingham, United Kingdom, B15 2TH|
Sponsors and Collaborators
Department of Health, United Kingdom
|Principal Investigator:||Jerry Marsden, Dr||University Hospitals Birmingham NHS Foundation Trust|