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

University of Kansas

Status and phase: Active, not recruiting; Phase 1

Conditions: Squamous Cell Carcinoma; Cutaneous Squamous Cell Carcinoma; Basal Cell Carcinoma

Treatments: Drug: Copaxone

Study type: Interventional

Funder types: Other

Identifiers

NCT03982212

IIT-2018-Copax-HN

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intratumoral Copaxone

Experimental group

Description:

Eligible 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.

Treatment:

Drug: Copaxone