Condition category
Cancer
Date applied
17/09/2009
Date assigned
19/11/2009
Last edited
07/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.stgeorges.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes