Contact information
Type
Scientific
Primary contact
Prof Angus Dalgleish
ORCID ID
Contact details
Cellular and Molecular Medicine
Level 2 Jenner Wing
St George's University London
Cranmer Terrace
London
SW17 0RE
United Kingdom
+44 (0)20 8725 0809
dalgleis@sgul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Combined Local Immunotherapy and Radiotherapy in metastatic Melanoma: an interventional single-arm trial
Acronym
CLIRM-1
Study hypothesis
Malignant melanoma lesions can be cleared using a combination of local immunotherapy (Toll-like receptor [TLR] agonists and interleukin-2 [IL-2]) and radiotherapy.
Ethics approval
Wandsworth Research Ethics Committee, approval pending as of 17/09/2009
Study design
Interventional single-arm single-centre trial
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Please contact Dr Janet Fernihough at janet@fischertrust.org for patient information sheet
Condition
Metastatic melanoma
Intervention
All participants will receive the following treatments:
1. Aldara® cream applied four times weekly. Each sachet of 250 mg is sufficient to cover 20 square centimeters, so amount of cream used depends on the size of the lesion.
2. Intralesional injections of Proleukin® and Hiltonol®:
2.1. Proleukin® will be diluted to a concentration of 10 micrograms interleukin-2 per millilitre (10 ugml). Each lesion will have 100 microlitre injections, up to three in number depending on the size of the lesion. This will be performed three times weekly.
2.2. Hiltonol® is a 2 mg/ml solution and again, 100 microlitre injections will be made intralesionally, with a maximum of three injections per lesion, three times weekly.
3. Local radiotherapy
The total duration will be one year if the treatment is effective, but we anticipate an average of 36 weeks, depending on the choice of radiotherapy schedule.
Intervention type
Drug
Phase
Not Applicable
Drug names
Imiquimod (Aldara®), aldesleukin (Proleukin®), poly-ICLC (Hiltonol®)
Primary outcome measure
Size of lesion
All primary and secondary outcome measures will be measured formally at entry, after 1 month, 6 months and end of trial.
Secondary outcome measures
1. Toxicity associated with this treatment will be measured by the number of adverse and serious adverse events during treatment, and the number of injections delayed in case of excessive local reaction.
2. Frequency and latency of appearance of any new skin lesions local or distal to the treated area will be recorded
3. Levels of markers associated with tumour infiltrating lymphocytes and tumour associated macrophages will be estimated by real time polymerase chain reaction (RT-PCR) of material biopsied from the lesions
4. Systemic immune responses associated with this treatment will be assessed by analysis of serum levels of cytokines and white blood cell properties taken by blood sampling during treatment.
All primary and secondary outcome measures will be measured formally at entry, after 1 month, 6 months and end of trial.
Overall trial start date
01/01/2010
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females, aged 16 to 85 years
2. Patients who have one or more malignant skin tumours confirmed histologically at diagnosis
3. Patients with malignant skin tumours for whom other standard therapy options are no longer appropriate or have been refused by the patient
4. Life expectancy of at least 3-6 months
5. Patients with a WHO performance status of 0, 1 or 2
6. Patients who are informed of and are willing and able to comply with the home application of the Aldara® cream
7. Patients who are willing and able to comply with the investigational nature of the study and who have signed a written informed consent form
8. Patients who are willing to receive the number of intra-lesional injections and biopsies required to complete the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Patients with unstable or severe current medical conditions or active, uncontrolled infection
2. Patients with psychological or sociological conditions, addictive disorders or family problems which would preclude compliance with the protocol
3. Patients undergoing therapy at study entry with other investigational agents that are directly immunosuppressive
4. Patients having procreative potential who are not using adequate contraception
5. Patients with untreated/uncontrolled brain tumours
6. Patients with brain tumours which have been treated but which have not been stable for 3 or more months
7. Patients with known hypersensitivity to Hiltonol®, IL-2, Aldara®, cyclophosphamide (for patients 16 30) or any of the excipients
8. Any condition, which, in the opinion of the investigator might interfere with the safety of the patient or evaluation of the study objectives
Recruitment start date
01/01/2010
Recruitment end date
31/12/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St George's University London
London
SW17 0RE
United Kingdom
Sponsor information
Organisation
St George's Healthcare NHS Trust (UK)
Sponsor details
St George's Hospital London
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Application to Cancer Vaccine Institute (UK) in progress as of 17/09/2009.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list