Status:
WITHDRAWN
Intralesional Sclerosant for in Transit and Cutaneous Melanoma Metastases
Lead Sponsor:
Melanoma Institute Australia
Conditions:
Melanoma
In-Transit Metastasis of Cutaneous Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, othe...
Detailed Description
Many patients with metastatic melanoma have in transit and other cutaneous metastases. Untreated, these lesions become eroded, haemorrhagic and symptomatic. When systemic therapy is not warranted, has...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03754140
Start Date
May 20 2020
End Date
December 1 2022
Last Update
July 14 2022
Active Locations (1)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050