Clinical trial NCT03982212: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cutaneous Squamous Cell Carcinoma
Squamous Cell Carcinoma
Basal Cell Carcinoma
Keywords: Copaxone
Window of Opportunity Trial
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, open-label, preoperative, window of opportunity trial.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of participants that experience Treatment Related Adverse Events (TRAEs) or Treatment Related Serious Adverse Events (TRSAEs)
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Immune Biomarker Level
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Fairway
country: United States
facility: University of Kansas Cancer Center - CRC
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Cancer Center, Westwood Campus
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
Study officials:
affiliation: The University of Kansas Cancer Center
name: Joaquina Baranda, MD
role: PRINCIPAL_INVESTIGATOR
References: