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

Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03982212
• Other study ID #: IIT-2018-Copax-HN
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 26, 2019
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: July 2024
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation until the end of study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately.

• Men of child-bearing potential must not father a child or donate sperm while on this study until the end of study treatment.

• Physician feels the patient is medically fit for the trial.

Exclusion Criteria:

• Current or anticipated use of other investigational agents while participating in this study.

• Pregnant or breast feeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants (if applicable) Planned treatment with chemotherapy and/or radiation therapy prior to standard of care surgery. Concurrent treatment with anti-cancer therapy is not allowed.

• 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.

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Cutaneous Squamous Cell Carcinoma
• Squamous Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Cancer Center - CRC	Fairway	Kansas
United States	The University of Kansas Cancer Center, Westwood Campus	Kansas City	Kansas
United States	University of Kansas Cancer Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants that experience Treatment Related Adverse Events (TRAEs) or Treatment Related Serious Adverse Events (TRSAEs)	Participants will be evaluated for TRAEs and TRSAEs from the time of the first injection (Day 1) through the time they go to surgery. TRAEs and TRSAEs will be evaluated per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	up to 6 weeks
Secondary	Immune Biomarker Level	The Human V2 nCounter® Immunology Panel (NanoString Technologies) will be used to measure the difference of immune biomarker levels at pre-treatment and post-treatment.	Up to 6 weeks