Cutaneous Squamous Cell CarcinomaPhase 1NCT03982212
A Window of Opportunity Trial of Intratumoral Injection of Copaxone® in Patients With Percutaneously Accessible Tumors
A Phase 1 study testing Copaxone in people with Cutaneous Squamous Cell Carcinoma and Squamous Cell Carcinoma, run by University of Kansas Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma, Squamous Cell Carcinoma, Basal Cell Carcinoma
- What is being tested?
- Copaxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jul 2019to Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
University of Kansas Cancer Center - CRC
Fairway, Kansas, 66205
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
University of Kansas Cancer Center
Kansas City, Kansas, 66205
About this study
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.
- Being tested
- Copaxone
- Keywords
- Copaxone, Window of Opportunity Trial
- Medical subject headings
- Carcinoma, Squamous Cell, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CopaxoneDrug
Also called Glatiramer acetate, Glatopa
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Copaxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 6 weeks
Secondary outcomes (1)
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.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start26 Jul 2019
- Primary completion7 Dec 2022
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open-label, preoperative, window of opportunity trial.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joaquina Baranda, MD, Principal investigator, The University of Kansas Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982212
- Sponsor's protocol ID
- IIT-2018-Copax-HN
- Status last verified
- May 2023
- First submitted
- 7 Jun 2019
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40230575
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Window of Opportunity Trial of Intratumoral Injection of Copaxone® in Patients With Percutaneously Accessible Tumors
- ClinicalTrials.gov ID
- NCT03982212
- Acronym / sponsor ID
- IIT-2018-Copax-HN
- Keywords
- Copaxone, Window of Opportunity Trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- Jul 2024 (estimated)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open-label, preoperative, window of opportunity trial.
| Arm | Type | Receives |
|---|---|---|
| Intratumoral Copaxone | Experimental | Drug: CopaxoneEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CopaxoneAlso: Glatiramer acetate, Glatopa* 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. | Drug | Intratumoral Copaxone |
Primary outcome
Proportion of participants that experience Treatment Related Adverse Events (TRAEs) or Treatment Related Serious Adverse Events (TRSAEs)
Time frame: up to 6 weeks
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
1 secondary outcome
Immune Biomarker Level
Time frame: Up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Derived from this study: PubMed 40230575Baranda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joaquina Baranda, MD principal investigator
The University of Kansas Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Copaxone in people with Cutaneous Squamous Cell Carcinoma and Squamous Cell Carcinoma, run by University of Kansas Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants that experience Treatment Related Adverse Events (TRAEs) or Treatment Related Serious Adverse Events (TRSAEs) (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.