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Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face (PICAMEL)

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ClinicalTrials.gov Identifier: NCT02723721
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:

Non-invasive lentigo maligna (LM) is characterized by an in situ proliferation of melanoma cells, limited to the epidermis. It is found most commonly on the head and neck of elderly persons, with a peak incidence in the seventh or eighth decade. If untreated, it may develop into invasive melanoma. The gold standard treatment for LM is surgery using a 5-10 mm margin. However, the lesions can be large, and conventional surgery can be difficult, particularly on the face.

Then, there is a need for a topical non-surgical treatment of LM. Ingenol mebutate (IM)/Picato® is able to induce cell apoptosis and an inflammatory reaction in the epidermis and superficial dermis.

Thus, the investigators hypothesize that the topical use of Picato® could induce the cure or a prolonged remission of non-invasive LM.

Because of the exploratory phase of this study (no case report and no clinical trial at the early phase of designing this study, only one case report at the time of submission of this form) the investigators will conduct an open label study limited to patients who are not eligible to, or who refuse surgical treatment of their LM.

The main objective of this study is to determine the proportion of patients with complete response (CR) obtained 2 months after one or two cycles (for patients who did not respond to the first cycle) of topical treatment by IM 150 µg/g for non-invasive LM of the face (head and neck).


Condition or disease Intervention/treatment Phase
Lentigo Maligna Drug: Picato gel Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face - Study PICAMEL
Study Start Date : June 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Picato gel
application on1 cm around the lesion, 0.47 g of Picato® gel 150 µg/g, once a day on 3 consecutive days.
Drug: Picato gel
apply on and 1 cm around the lesion, 0.47 g of Picato® gel 150 µg/g, once a day on 3 consecutive days.




Primary Outcome Measures :
  1. the clinical and histological complete response (CR) of non-invasive LM 2 months after the end of a treatment cycle. In case of failure of the first cycle, a second will be realized and the CR will be re-assessed at 4.5 months [ Time Frame: at 2 months after end of treatment ]

Secondary Outcome Measures :
  1. disease-free survival [ Time Frame: maximum of 36 months ]
    calculated from the date of the CR and the date of relapse or death related to the non-invasive LM (very unlikely here). Relapse is defined as the clinical appearance of a new pigmented lesion with histopathological analysis, from one or more biopsy (s), which confirms the diagnosis of non-invasive LM.

  2. side effects [ Time Frame: at 36 months ]
    • The type, frequency, severity and the time to onset of side effects will be reported. The side effects will be classified into grades according to WHO criteria and also using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The intensity of short-term local side effects will be evaluated by the Local Skin Reaction score

  3. specific diagnostic signs of treatment failure [ Time Frame: maximun of 36 months ]
  4. relapse of non-invasive LM [ Time Frame: maximum of 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject of both sexes at least 18 years of age
  • Patient with a noninvasive LM of the head (face or scalp) which has been proven by biopsy
  • LM with a surface area equal or superior to 1 cm2
  • Patient who is not eligible to, or refuse surgical treatment
  • LM which has not been treated previously or which has already been treated surgically (one or several time) but which is relapsing or which could not been completely removed
  • ECOG (Eastern Cooperative Oncology Group) ≤2
  • Patient affiliated to French social security
  • Patient able to understand and communicate with the investigator and to comply with the requirements of the study
  • Patient must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations

Exclusion Criteria:

Location of the LM:

  • on the eyelids or within 1 cm of the eyelids
  • within 1 cm of the lips
  • within 5 cm of an incompletely healed wound
  • elsewhere than on the head

    • LM which is not strictly intraepidermal, which has an invasive component on the biopsy performed at screening visit
    • LM which has had in the past an invasive component, even if it has been surgically treated
    • Melanoma of another histopathologic type than LM
    • LM with a surface area to be treated (including the 1cm surrounding normal skin) > 25 cm2
    • LM whose borders cannot be easily defined
    • Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
    • Patient treated with topical steroids or others immunosuppressives drugs (local or systemic agents) within 30 days of entry into this trial
    • Patient with active malignancy (other than LM) or a previous malignancy within the past 3 years; except for patient with resected basal cell carcinoma, resected cutaneous squamous cell carcinoma , resected carcinoma in-situ of the cervix, and resected carcinoma in-situ of the breast
    • Past medical history record of infection with human immunodeficiency virus
    • Organ transplant recipient
    • Immunosuppressed subject
    • Women of child-bearing potential, or pregnant or lactating
    • History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area (e.g., eczema, unstable psoriasis, xeroderma pigmentosum).
    • Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment area within 2 years prior to visit 1
    • Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment area.
    • Current enrolment or participation in a clinical trial within 30 days of entry into this trial
    • Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723721


Contacts
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Contact: Henri MONTAUDIE, PH montaudie.h@chu-nice.fr
Contact: Vanina OLIVERI, CRA oliveri.v@chu-nice.fr

Locations
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France
AP-HP Hopital Avicenne Not yet recruiting
Bobigny, France, 93000
Contact: Liliane LAROCHE, PU-PH         
AP-HP Hôpital Ambroise Paré Not yet recruiting
boulogne Billancourt, France
Contact: Philippe SAIAG, PH         
Hôpital du Morvan Not yet recruiting
Brest, France
Contact: Laurent MISERY, PU-PH         
CHRU de Lille Recruiting
Lille, France
Contact: Laurent MORTIER, PU-PH         
CHU de Nantes Not yet recruiting
Nantes, France
Contact: Brigitte DRENO, PU-PH         
CHU de Nice Recruiting
Nice, France, 06000
Principal Investigator: Henri MONTAUDIE, PH         
Hôpital Pontchaillou Not yet recruiting
Rennes, France
Contact: Alain DUPUY, PU-PH         
CHU de Saint Etienne Recruiting
Saint Etienne, France
Contact: Frederic CAMBAZARD, PU-PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Henri MONTAUDIE, PH Centre Hospitalier Universitaire de Nice

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02723721     History of Changes
Other Study ID Numbers: 15-PP-14
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Nice:
Lentigo maligna

Additional relevant MeSH terms:
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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