Trials / Unknown
UnknownNCT03982212
A Window of Opportunity Trial of Intratumoral Injection of Copaxone® in Patients With Percutaneously Accessible Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- University of Kansas Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The investigator believes that injecting Copaxone into tumors will help participants immune system fight cancer. This has been studied in mice and has shown encouraging results. Copaxone is a safe medication currently used to treat Multiple Sclerosis (MS) and has very few side effects. To be considered for this trial a tumor must be easy to be injected and must be at least the size of a pea. Participants will be closely monitored for any side effects. Tissue from before surgery will be compared to tissue after the treatment and surgery to be checked for immune response and anti-tumor effects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Copaxone | * Agent: Glatiramer acetate (Copaxone®) * Dose: 40 mg * Route: Intratumoral injection * Schedule: At least 1 dose, up to 3 doses, with each dose being at least 48 hours apart and last dose within 96 hours of standard of care surgery. |
Timeline
- Start date
- 2019-07-26
- Primary completion
- 2022-12-07
- Completion
- 2024-07-01
- First posted
- 2019-06-11
- Last updated
- 2023-05-19
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03982212. Inclusion in this directory is not an endorsement.