Overview

Intralesional Sclerosant for in Transit and Cutaneous Melanoma Metastases

Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Melanoma Institute Australia
Treatments:
Polidocanol
Sclerosing Solutions
Criteria
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.