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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03754140




Registration number
NCT03754140
Ethics application status
Date submitted
31/10/2018
Date registered
27/11/2018
Date last updated
21/05/2020

Titles & IDs
Public title
Intralesional Sclerosant for in Transit and Cutaneous Melanoma Metastases
Scientific title
Intralesional Sclerosant for in Transit and Cutaneous Melanoma Metastases
Secondary ID [1] 0 0
HREC/18/RPAH 621
Universal Trial Number (UTN)
Trial acronym
INTRANS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
In-Transit Metastasis of Cutaneous Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Polidocanol Injection

Experimental: Polidocanol Injection - Polidocanol (3%) 0.1ml intralesional injection per 10mm diameter lesion


Treatment: Drugs: Polidocanol Injection
Sclerotic agent

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical efficacy of interlesional polidocanol injection assessed by the size of in transit melanoma metastases after treatment - 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)
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Incidence of treatment related adverse events - Treatment related adverse events using the CTCAE version 4 terms and grading.
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Bystander treatment effect on untreated intransit melanoma metastases - Proportion of patients with a complete response (complete disappearance of untreated lesions), partial response (a 25% or more reduction in size of untreated lesions), stable disease (a 0 to 24% reduction in size of untreated lesions) or disease progression (any increase in size of untreated lesions)
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Bystander treatment effect on the proportion of tumour infiltrating immune markers in treated and untreated melanoma lesions - The proportion (%) of tumour-infiltrating immune markers: CD4, CD8 and FoxP3 T cell markers, CD20 (B cell), CD16 and CD56 Natural Killer (NK) cell markers, Ki67 marker of proliferation, CD31 (endothelial cells) and CD68 and CD163 (macrophages) detected at baseline and 1 week after intralesional injection by immunohistochemistry. The same analysis will be undertaken in a minimuim of one untreated lesion detected at baseline and at anytime between 1 and 8 weeks. Change in the proportion (%) of immune markers will be ,made within each lesion and between each lesion.
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Bystander treatment effect on tumour viabilty in treated and untreated melanoma lesions - The proportion of residual non-necrotic melanoma cells detected histolologcally in treated and untreated lesions one week after intralesional injection.
Timepoint [4] 0 0
8 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown

Funding & Sponsors
Primary sponsor type
Other
Name
Melanoma Institute Australia
Address
Country

Ethics approval
Ethics application status

Summary
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, 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.
Trial website
https://clinicaltrials.gov/show/NCT03754140
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Diona Damian
Address 0 0
Royal Prince Alfred Hospital, Sydney, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Diona Damian
Address 0 0
Country 0 0
Phone 0 0
+612 9515 8331
Fax 0 0
Email 0 0
diona.damian@health.nsw.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03754140