Effect of Topical Imiquimod on Lentigo Maligna (LIMIT-1)
This study has been completed.
Sponsor:
Jerry Marsden
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
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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
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 May 16, 2013