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Trial record 6 of 175 for:    The University of Kansas Cancer Center | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03982212
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Cutaneous Squamous Cell Carcinoma Squamous Cell Carcinoma Basal Cell Carcinoma Drug: Copaxone Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, open-label, preoperative, window of opportunity trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Window of Opportunity Trial of Intratumoral Injection of Copaxone® in Patients With Percutaneously Accessible Tumors
Actual Study Start Date : July 26, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intratumoral Copaxone
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.
Drug: Copaxone
  • 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.
Other Names:
  • Glatiramer acetate
  • Glatopa




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Immune Biomarker Level [ Time Frame: Up to 6 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982212


Contacts
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Contact: Clinical Trials Nurse Navigator 913-945-7552 ctnursenav@kumc.edu

Locations
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United States, Kansas
University of Kansas Cancer Center - CRC Recruiting
Fairway, Kansas, United States, 66205
Contact: Clinical Trials Nurse Navigator    913-945-7552    ctnursenav@kumc.edu   
The University of Kansas Cancer Center, Westwood Campus Recruiting
Kansas City, Kansas, United States, 66205
Contact: Clinical Trials Nurse Navigator    913-945-7552    ctnursenav@kumc.edu   
University of Kansas Cancer Center Recruiting
Kansas City, Kansas, United States, 66205
Contact: Clinical Trials Nurse Navigator    913-945-7552    ctnursenav@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Joaquina Baranda, MD The University of Kansas Cancer Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03982212     History of Changes
Other Study ID Numbers: IIT-2018-Copax-HN
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas Medical Center:
Copaxone
Window of Opportunity Trial

Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Basal Cell
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Glatiramer Acetate
(T,G)-A-L
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents