Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Angus Dalgleish


Contact details

Cellular and Molecular Medicine
Level 2 Jenner Wing
St George's University London
Cranmer Terrace
SW17 0RE
United Kingdom
+44 (0)20 8725 0809

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Combined Local Immunotherapy and Radiotherapy in metastatic Melanoma: an interventional single-arm trial



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


Secondary study design


Trial setting


Trial type


Patient information sheet

Please contact Dr Janet Fernihough at for patient information sheet


Metastatic melanoma


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

St George's University London
SW17 0RE
United Kingdom

Sponsor information


St George's Healthcare NHS Trust (UK)

Sponsor details

St George's Hospital London
Blackshaw Road
SW17 0QT
United Kingdom

Sponsor type




Funder type


Funder name

Application to Cancer Vaccine Institute (UK) in progress as of 17/09/2009.

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes

12/12/2017: No publications found in PubMed, verifying study status with principal investigator.