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Effect of Topical Imiquimod on Lentigo Maligna (LIMIT-1)

Primary Purpose

Lentigo Maligna

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Imiquimod
Sponsored by
Jerry Marsden
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lentigo Maligna

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • Taking immunosuppressive medication.
  • Taking part in any other intervention study.

Sites / Locations

  • Dr J Marsden

Outcomes

Primary Outcome Measures

Pathological complete regression (PCR) in the mapped biopsied and resected LM using 2 mm slices.

Secondary Outcome Measures

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.
Clinical feasibility of imiquimod treatment
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
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.
Measurement of hypothetical treatment preferences for surgery or imiquimod for LM using standard gamble technique.

Full Information

First Posted
June 24, 2010
Last Updated
June 18, 2012
Sponsor
Jerry Marsden
Collaborators
Department of Health, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT01161888
Brief Title
Effect of Topical Imiquimod on Lentigo Maligna
Acronym
LIMIT-1
Official Title
Effect of Topical Imiquimod on Lentigo Maligna
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jerry Marsden
Collaborators
Department of Health, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lentigo Maligna

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Imiquimod
Other Intervention Name(s)
Aldara 5% cream
Intervention Description
250mg sachets to be applied at a start dose of 5 days a week. Dose will be adjusted using an algorithm according to tolerability.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Clinical assessment of response after imiquimod treatment
Description
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
Title
Clinical feasibility of imiquimod treatment
Description
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
Title
Number of consultations with NHS staff during imiquimod treatment
Time Frame
Assessed up to week 12 visit
Title
Frequency of functional T cell responses recognising peptide epitopes in melanocyte differentiation and cancer-testis antigens.
Description
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.
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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). Taking immunosuppressive medication. Taking part in any other intervention study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Marsden, Dr
Organizational Affiliation
University Hospital Birmingham NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr J Marsden
City
Queen Elizabeth Hospital, Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom

12. IPD Sharing Statement

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Effect of Topical Imiquimod on Lentigo Maligna

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