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

NCT03982212 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: IIT-2018-Copax-HN
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Cutaneous Squamous Cell Carcinoma; Squamous Cell Carcinoma; Basal Cell Carcinoma

Keywords

Copaxone; Window of Opportunity Trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Immune Biomarker Level

  Up to 6 weeks

Study Arms (1)

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.

Drug: Copaxone

Interventions

Copaxone DRUG

* 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.

Also known as: Glatiramer acetate, Glatopa

Intratumoral Copaxone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (3)

University of Kansas Cancer Center - CRC

Fairway, Kansas, 66205, United States

Location

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66205, United States

Location

Related Publications (1)

• 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.

  PMID: 40230575 DERIVED

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Carcinoma, Basal Cell

Interventions

Glatiramer Acetate; Coat Protein Complex I

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Vesicular Transport Proteins; Membrane Proteins; Proteins

Study Officials

• Joaquina Baranda, MD

  The University of Kansas Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm, open-label, preoperative, window of opportunity trial.

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 11, 2019
• Study Start: July 26, 2019
• Primary Completion: December 7, 2022
• Study Completion: July 1, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)