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

  • STATUS
    Recruiting
  • End date
    Jul 24, 2024
  • participants needed
    10
  • sponsor
    University of Kansas Medical Center
Updated on 24 May 2022
cancer
carcinoma
squamous cell carcinoma
copaxone

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.

Details
Condition Cutaneous Squamous Cell Carcinoma, Squamous Cell Carcinoma, Basal Cell Carcinoma
Treatment Copaxone
Clinical Study IdentifierNCT03982212
SponsorUniversity of Kansas Medical Center
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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