Clinical trial · Interventional
Intralesional Sclerosant for in Transit and Cutaneous Melanoma Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to identify eligible patients within planned timeframe
Summary
Brief summary (as posted)
There is currently an urgent need for low cost and well tolerated intralesional agents for the management of in transit and cutaneous melanoma metastases that are unsuitable for, or resistant to, other therapies. This pilot study will determine whether intralesional injections of the sclerosant polidocanol into intransit and cutaneous melanoma lesions shows promise for efficacy, safety and ease of use that will enable this inexpensive and widely available agent to undergo further evaluation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| In-Transit Metastasis of Cutaneous Melanoma | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polidocanol Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Polidocanol Injection
- description
- Polidocanol (3%) 0.1ml intralesional injection per 10mm diameter lesion
- interventionNames
- Drug: Polidocanol Injection
Primary outcomes (1)
- measure
- Clinical efficacy of interlesional polidocanol injection assessed by the size of in transit melanoma metastases after treatment
- timeFrame
- 8 weeks
- description
- Proportion of patients with a complete response (complete disappearance of treated lesions), partial response (a 25% or more reduction in size of treated lesions), stable disease (a 0 to 24% reduction in size of treated lesions) or disease progression (any increase in size of treated lesions)
Secondary outcomes (4)
- measure
- Incidence of treatment related adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed in transit and/or cutaneous melanoma metastases unsuitable for, or with progressive disease despite systemic, surgical, intra-arterial, topical or radiation therapies * A minimum of 2 accessible lesions Exclusion Criteria: * Periocular lesions * Severe renal impairment defined as an estimated glomerular filtration rate \<20ml/min/1.73sqm * Sever liver function abnormality defined as aspartate aminotransferase and / or alanine aminotransferase \> 3 x upper limit of normal and / or bilirubin \> 1.5 x upper limit of normal * known hypersensitivity to polidocanol or its exipients * Patients unavailble for the full study duration (of a 4 week screening period and 8 week treatment period) because of general frailty, geographical or social reasons * Pregnant or breast feeding female patients * Patients receiving topical or radiation therapy to the in transit and / or cutaneous lesions within 4 weeks of planned start of study treatment (patients receiving current systemic immunotherapy which is deemed appropriate to continue, despite progression of disease in the skin, in order to reduce the likelihood of visceral metastases are eligible) * Patients receiving sclerosants for other indications within 4 weeks of planned start of study treatment or during study treatment.
References
Publications (0)
Data not yet available