Metastatic melanoma Cancer Malignant melanoma of skin
Conditions
Interventions
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
Sponsors
St George's Healthcare NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed