Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT03754140 |
Other study ID # |
HREC/18/RPAH 621 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
May 20, 2020 |
Est. completion date |
December 2022 |
Study information
Verified date |
July 2022 |
Source |
Melanoma Institute Australia |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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 failed or is not tolerated for in transit disease, and when surgery is
not feasible or appropriate, other local treatments are needed. Current options include
isolated limb infusion for bulky limb disease, topical immunotherapy with contact sensitisers
and imiqiuimod for superficial, nonbulky disease or radiation therapy. Intralesional (IL)
agents such as Rose Bengal (PV-10, Provectus) and Talimogene laherparepvec (T-Vec, Amgen)
have been used for patients with limited numbers of cutaneous metastases with reported
overall response rates of 51% and 26% respectively. It is thought that these IL agents can
incite regional or even systemic anti-tumour immune responses, thus providing benefit beyond
the individual injected lesions. Use of PV-10, which is not an intrinsic immune modulator,
was associated with regression of untreated bystander lesions in 27% of patients.
T-Vec is not currently available as a subsidised product in Australia and PV-10 is not
currently accessible outside of dual-agent systemic/IL clinical trials. Intralesional
injection of the antimetabolites 5-fluorouracil and methotrexate has been used successfully
for the treatment of cutaneous squamous cell carcinoma, but the efficacy of these agents in
melanoma is unknown. Importantly, the investigator's in transit melanoma patients usually
have multiple, often very numerous lesions, making IL injection with adequate volumes of
antimetabolites difficult without significant risk of systemic haematologic, hepatic and
renal side effects.
Hence there is currently an urgent need for tolerable, low cost and accessible intralesional
therapies for in transit and cutaneous melanoma metastases.
This study aims to evaluate the efficacy and tolerability of intralesional therapy with the
sclerosant polidocanol for treatment of in transit and cutaneously metastatic melanoma
unsuitable for other therapies.
Intravascularly injected sclerosants have a long history of safe and effective use in the
treatment of varicose veins. Sclerosants have also been used intralesionally for the
treatment of cutaneous lesions such as squamous cell carcinoma, pyogenic granulomas, Kaposi
sarcoma and angiomas. They are inexpensive, readily accessible and can be easily administered
in the clinic to multiple metastases. By inciting cell death within melanoma metastases in
the skin, they may also incite anti-tumour immune responses in untreated bystander lesions,
as is observed with IL PV-10 therapy.