A Window of Opportunity Trial of Intratumoral Injection of Copaxone® in Patients With Percutaneously Accessible Tumors

What Was Tested

In this phase 1 trial, researchers set out to test Glatiramer Acetate.

The investigator believes that injecting Copaxone into tumors will help participants immune system fight cancer.

It had 1 arm (groups): Intratumoral Copaxone (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 10 planned participants were the target.

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: Ability of participant or Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent. Have confirmed diagnosis of squamous cell cancer or cutaneous squamous cell cancer or basal cell carcinoma. Have one or more tumors measuring at least 5 mm in diameter. No prior therapy for this malignancy. Men of child-bearing potential must not father a child or donate sperm while on this study until the end of study treatment.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: current or anticipated use of other investigational agents while participating in this study; hypersensitivity to copaxone® or glatiramer acetate, mannitol, or any component of the formulation; A known condition that leads to immunosuppression such as Acquired Immunodeficiency Syndrome (AIDS) or concurrent use of immunosuppressive therapy.

How the Study Was Run

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

Nothing was hidden in this open-label Glatiramer Acetate study: the participants and staff both knew the treatment.

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

It started in 2019-07-26 with completion listed for 2022-12-07.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Proportion of participants that experience Treatment Related Adverse Events (TRAEs) or Treatment Related Serious Adverse Events (TRSAEs) (time frame: up to 6 weeks).

It also tracked 1 secondary outcome, for example Immune Biomarker Level.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Glatiramer Acetate in 10 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glatiramer Acetate compound page, all human trials.