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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copaxone | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joaquina Baranda, MD | The University of Kansas Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Cancer Center - CRC | Fairway | Kansas | 66205 | United States | ||
| The University of Kansas Cancer Center, Westwood Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40230575 | Derived | Baranda JC, Mohyuddin GR, Bur AM, Shnayder Y, Sweeney KR, Kakarala K, Prouty M, Pathak H, Puri R, Mitra A, Madan R, Forrest ML, Huang A, Weir S, Godwin AK, Alhakamy NA, Griffin JD, Berkland CJ. A window of opportunity trial evaluating intratumoral injection of Copaxone(R) in patients with percutaneously accessible tumors. Transl Med Commun. 2023;8:5. doi: 10.1186/s41231-023-00137-9. Epub 2023 Feb 27. |
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Single arm, open-label, preoperative, window of opportunity trial.
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|
| Kansas City |
| Kansas |
| 66205 |
| United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66205 | United States |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D018295 | Neoplasms, Basal Cell |
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| ID | Term |
|---|---|
| D000068717 | Glatiramer Acetate |
| D020755 | Coat Protein Complex I |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D033921 | Vesicular Transport Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
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