Clinical Trials /

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

NCT03982212

Description:

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.

Related Conditions:
  • Basal Cell Carcinoma
  • Skin Squamous Cell Carcinoma
  • Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Window of Opportunity Trial of Intratumoral Injection of Copaxone® in Patients With Percutaneously Accessible Tumors
  • Official Title: A Window of Opportunity Trial of Intratumoral Injection of Copaxone® in Patients With Percutaneously Accessible Tumors

Clinical Trial IDs

  • ORG STUDY ID: IIT-2018-Copax-HN
  • NCT ID: NCT03982212

Conditions

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

Interventions

DrugSynonymsArms
CopaxoneGlatiramer acetate, GlatopaIntratumoral Copaxone

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Intratumoral CopaxoneExperimentalEligible subjects receive at least 1 and up to 3 doses of Copaxone® 40 milligrams (mg) intratumorally prior to standard of care surgery. The doses will be administered at least 48 hours apart. The last dose will be given within 96 hours of standard of care surgery.
  • Copaxone

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion of participants that experience Treatment Related Adverse Events (TRAEs) or Treatment Related Serious Adverse Events (TRSAEs)
Time Frame:up to 6 weeks
Safety Issue:
Description: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

Secondary Outcome Measures

Measure:Immune Biomarker Level
Time Frame:Up to 6 weeks
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Kansas Medical Center

Trial Keywords

  • Copaxone
  • Window of Opportunity Trial

Last Updated

May 3, 2021