Combined Local Immunotherapy and Radiotherapy in metastatic Melanoma
| ISRCTN | ISRCTN26232057 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26232057 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/09/2009
- Registration date
- 19/11/2009
- Last edited
- 12/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Angus Dalgleish
Scientific
Scientific
Cellular and Molecular Medicine
Level 2 Jenner Wing
St George's University London
Cranmer Terrace
London
SW17 0RE
United Kingdom
| Phone | +44 (0)20 8725 0809 |
|---|---|
| dalgleis@sgul.ac.uk |
Study information
| Study design | Interventional single-arm single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Please contact Dr Janet Fernihough at janet@fischertrust.org for patient information sheet |
| Scientific title | Combined Local Immunotherapy and Radiotherapy in metastatic Melanoma: an interventional single-arm trial |
| Study acronym | CLIRM-1 |
| Study objectives | 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(s) | Wandsworth Research Ethics Committee, approval pending as of 17/09/2009 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2010 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St George's University London
London
SW17 0RE
United Kingdom
SW17 0RE
United Kingdom
Sponsor information
St George's Healthcare NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
St George's Hospital London
Blackshaw Road
Tooting
London
SW17 0QT
England
United Kingdom
| Website | http://www.stgeorges.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/039zedc16 |
Funders
Funder type
Charity
Application to Cancer Vaccine Institute (UK) in progress as of 17/09/2009.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
12/12/2017: No publications found in PubMed, verifying study status with principal investigator.
