A Window of Opportunity Trial of Intratumoral Injection of Copaxone® in Patients With Percutaneously Accessible Tumors
Primary Purpose
Cutaneous Squamous Cell Carcinoma, Squamous Cell Carcinoma, Basal Cell Carcinoma
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Copaxone
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Squamous Cell Carcinoma focused on measuring Copaxone, Window of Opportunity Trial
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.
Sites / Locations
- University of Kansas Cancer Center - CRC
- The University of Kansas Cancer Center, Westwood Campus
- University of Kansas Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intratumoral Copaxone
Arm 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03982212
First Posted
June 7, 2019
Last Updated
May 18, 2023
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03982212
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 26, 2019 (Actual)
Primary Completion Date
December 7, 2022 (Actual)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Squamous Cell Carcinoma, Squamous Cell Carcinoma, Basal Cell Carcinoma
Keywords
Copaxone, Window of Opportunity Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single arm, open-label, preoperative, window of opportunity trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intratumoral Copaxone
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Copaxone
Other Intervention Name(s)
Glatiramer acetate, Glatopa
Intervention Description
Agent: Glatiramer acetate (Copaxone®)
Dose: 40 mg
Route: Intratumoral injection
Schedule: At least 1 dose, up to 3 doses, with each dose being at least 48 hours apart and last dose within 96 hours of standard of care surgery.
Primary Outcome Measure Information:
Title
Proportion of participants that experience Treatment Related Adverse Events (TRAEs) or Treatment Related Serious Adverse Events (TRSAEs)
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
Time Frame
up to 6 weeks
Secondary Outcome Measure Information:
Title
Immune Biomarker Level
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.
Time Frame
Up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquina Baranda, MD
Organizational Affiliation
The University of Kansas Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Cancer Center - CRC
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
The University of Kansas Cancer Center, Westwood Campus
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Window of Opportunity Trial of Intratumoral Injection of Copaxone® in Patients With Percutaneously Accessible Tumors
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