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.
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
Drug | Synonyms | Arms |
---|
Copaxone | Glatiramer acetate, Glatopa | Intratumoral 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
Name | Type | Description | Interventions |
---|
Intratumoral Copaxone | Experimental | 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. | |
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