Intratumoral Injections of LL37 for Melanoma

What Was Tested

The trial (phase 1, phase 2) is built around LL-37 (cathelicidin).

Researchers also want to learn if LL37 can stimulate the immune system to help control the disease.

It had 1 arm (groups): Intra-Tumoral Injection of LL37 (experimental).

The registry classes the interventions as biological and other.

More on the Plan

Study Drug Administration: One (1) time a week for 8 weeks, LL37 will be injected into 2-4 tumors.

The injections will be done in the clinic.

Study Visits: Within 1 week before your first study drug injection: * You will have a physical exam. * You will have a punch biopsy of a tumor.

Your private areas will be covered (as much as possible), and a picture of your face will not be taken unless there are tumors on your face.

Who Took Part

The registry lists 4 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age greater than or equal to 18 years. Clinical performance status of ECOG 0-2 within 30 days of signing informed consent. Platelet count greater than or equal to 100,000/mm\^3. Serum ALT and AST less than three times the upper limit of normal. Seronegative for HIV antibody.

The full record lists 11 inclusion and 8 exclusion criteria; among the exclusions: active autoimmune disease requiring disease modifying therapy; concurrent systemic steroid therapy; any form of active primary or secondary immunodeficiency.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the LL-37 (cathelicidin) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-07-08 with completion listed for 2020-11-24.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Number of Participants With Antitumor Immune Response of Intra-Tumoral Injection of LL37.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of LL-37 (cathelicidin) in 4 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the LL-37 (cathelicidin) compound page, all human trials.