Intralesional Sclerosant for in Transit and Cutaneous Melanoma Metastases

NCT03754140 | Withdrawn Phase 2

• 1 other identifier: HREC/18/RPAH 621
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; In-Transit Metastasis of Cutaneous Melanoma

Keywords

Sclerosant; Polidocanol

Outcome Measures

Primary Outcomes (1)

• 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)

  8 weeks

Secondary Outcomes (4)

• Incidence of treatment related adverse events

  8 weeks

• Bystander treatment effect on untreated intransit melanoma metastases

  8 weeks

• Bystander treatment effect on the proportion of tumour infiltrating immune markers in treated and untreated melanoma lesions

  8 weeks

• Bystander treatment effect on tumour viabilty in treated and untreated melanoma lesions

  8 weeks

Study Arms (1)

Polidocanol Injection

EXPERIMENTAL

Polidocanol (3%) 0.1ml intralesional injection per 10mm diameter lesion

Drug: Polidocanol Injection

Interventions

Polidocanol Injection DRUG

Sclerotic agent

Also known as: Aethoxysklerol

Polidocanol Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Melanoma Institute Australia: lead

Study Sites (1)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

MeSH Terms

Conditions

Melanoma

Interventions

Polidocanol

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Diona Damian

  Royal Prince Alfred Hospital, Sydney, Australia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, single arm pilot study

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 27, 2018
• Study Start: May 20, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)