Clinical Trial: Effect of Topical Imiquimod on Lentigo Maligna

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Topical Imiquimod on Lentigo Maligna

Brief Summary: The purpose of this study is to determine if topical imiquimod is effective in the pathological complete regression of lentigo maligna.

Detailed Summary:
Sponsor: Jerry Marsden

Current Primary Outcome: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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) ]

Original Secondary Outcome:

• 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. These will be collected from the patient held diary and assessment by the investigator
  • Adherence to treatment schedule
  • Acceptability of imiquimod treatment. This will be collected by a visual analogue scale completed weekly by the participant.
  • Number and reasons for withdrawal from 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) ]

Dates:
Date Received: June 24, 2010
Date Started: June 2010
Date Completion:
Last Updated: June 18, 2012
Last Verified: May 2010