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

This study has been completed.
Sponsor:
Collaborator:
Department of Health, United Kingdom
Information provided by (Responsible Party):
Jerry Marsden, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01161888
First received: June 24, 2010
Last updated: June 18, 2012
Last verified: May 2010
  Purpose

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


Condition Intervention Phase
Lentigo Maligna
Drug: Imiquimod
Phase 4

Study Type: Interventional
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:


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 ]

Enrollment: 30
Study Start Date: June 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161888

Locations
United Kingdom
Dr J Marsden
Queen Elizabeth Hospital, Birmingham, United Kingdom, B15 2TH
Sponsors and Collaborators
Jerry Marsden
Department of Health, United Kingdom
Investigators
Principal Investigator: Jerry Marsden, Dr University Hospitals Birmingham NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Jerry Marsden, Consultant Dermatologist, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01161888     History of Changes
Other Study ID Numbers: LIMIT-1
Study First Received: June 24, 2010
Last Updated: June 18, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Lentigo
Hutchinson's Melanotic Freckle
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on September 16, 2014