None listed
Conditions
Brief summary
Study Details This study aims to compare two different non-invasive topical immunotherapies in patients with multiple, in-transit, cutaneous melanoma metastases. The hypothesis is that these treatments are at least as clinically effective as current therapies for patients with selective in-transit melanoma metastases and can be used to enhance patients’ quality of life and decrease health-related costs. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have been diagnosed with histologically or cytologically proven in-transit melanoma metastases, which are considered unsuitable for surgery. Intervention Description Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will be given imiquimod cream and asked to apply it to their lesions five times weekly for up to 12 months. Participants in the other group will be given diphenylcyclopropenone (DPCP) cream instead, and asked to apply it to their lesions once weekly for up to 12 months. All participants will undergo regular clinical review with measurement of the treated lesions and assessment of their lymph nodes, routine blood tests and CT/PET scans, in order to evaluate the response to treatment. Patients will also be asked to complete a questionnaire evaluating quality of life at 3, 6, 12, and 18 months. Study Outcomes The results of this study may lead to improved patient rated outcomes compared to current strategies through a reduction in the burden of local disease, fewer serious treatment-related complications, more convenient application, streamlined review and ultimately decreased healthcare-associated expenditure.
Interventions
The investigational agents are diphenylcyclopropenone (DPCP) and imiquimod, two dermatological immunotherapies for topical administration to cutaneous in-transit lesions. Each agent will be administered topically with a 5mm peripheral margin to uniformly treat between 5-20 target lesions over a minimum of 12 months or until complete clinical resolution of loco-regional disease.
Treatment Arm A – 5% Topical Imiquimod Cream: Self-application 5 times weekly, regular clinical review, time to best
The investigational agents are diphenylcyclopropenone (DPCP) and imiquimod, two dermatological immunotherapies for topical administration to cutaneous in-transit lesions. Each agent will be administered topically with a 5mm peripheral margin to uniformly treat between 5-20 target lesions over a minimum of 12 months or until complete clinical resolution of loco-regional disease. Treatment Arm A – 5% Topical Imiquimod Cream: Self-application 5 times weekly, regular clinical review, time to best response and formal 12 month assessment, regular clinical surveillance for duration of remaining trial. Treatment Arm B – Topical DPCP Cream: Sensitisation with 2% solution then treatment using 0.005% solution - titrated to effect to a maximum of 5% , Responders commence treatment regimen - self-application once weekly, regular clinical review, titration to effect, time to best response and formal 12 month assessment, regular clinical surveillance for duration of remaining trial. During the scheduled clinical review participants' records of dates (treatment log) of medication self-administration will be used to monitor adherence.
Sponsors
Professor B Mark Smithers
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men or women aged 18 years or older. 2. Willing and able to comply with study requirements. 3. Capable of providing valid (written and informed) consent. 4. Histologically or cytologically proven in-transit melanoma metastases. 5. Measurable disease between 2-15mm in diameter that can be accurately assessed by ruler/calliper. 6. Between 5 to 20 in-transit melanoma lesions. 7. Lesions present in anatomical locations amenable to imiquimod or DPCP treatment. 8. Cutaneous (superficial) macular, papular or small nodular in-transit melanoma deposits. 9. Considered un-suitable for surgery by the treating surgeon due to anatomical location or prohibitive disease factors or co-morbidities, previous treatment failure or patient refusal. 10. 12 weeks minimum duration between completing comparative treatments (ILI or PV-10) to prevent potentially confounding effects (treatment responses). 11. Patients must have, in the opinion of the investigator, adequate renal, haematopoietic and hepatic function, with no clinically significant impairment or uncontrolled haematological, hepatic or renal disease.
Exclusion criteria
1. Considered eligible for concurrent treatment with systemic chemo- or immunotherapies. 2. Subjects who have received chemotherapy or other systemic cancer therapy within 4 weeks of study. 3. Subjects who have received local treatment (e.g. surgery, cryotherapy, radiofrequency ablation) to the treatment area within four weeks of study treatment - to prevent potentially confounding effects (treatment responses/immunosuppression). 4. Life expectancy of less than 6 months or ECOG performance status equal or greater than 3. 5. Medical or psychiatric condition that compromises the patient’s ability to complete the treatment or follow-up assessments as per the protocol. 6. Unable or unwilling to provide fully informed consent and participate including patients with intellectual or mental impairment. 7. Patients who are pregnant or lactating. Women of child bearing potential must have a confirmed negative urine pregnancy test at study entry. 8. Known history of immumodeficiency including HIV, uncontrolled central nervous system metastases, concomitant systemic corticosteroid therapy, previous organ transplant. 9. Known severe concurrent or inter-current illness including: cardiovascular, respiratory or immunological) illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise their safety or compliance or interfere with interpretation of study results. 10. Previous severe adverse or allergic reaction to either treatment agent. 11. Patients unable or unwilling to comply with home application of treatment and the investigational nature of the study.
Outcome results
None listed