RECRUITING

Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)

Conditions

Cutaneous Squamous Cell Carcinoma Skin Cancers - Squamous Cell Carcinoma micro-needle array doxorubicin patch

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to test a new method of experimental treatment for cutaneous squamous cell skin cancer, using small adhesive-like patches (a micro-needle applicator or MNA for short), which have dozens of very small micro-needles loaded with extremely low doses of doxorubicin, a chemotherapy agent. The overall goal of this study is to test the safety and effectiveness of these patches. The investigators have established the highest tolerated dose at 50 micrograms in a previous study for a different type of cancer that affects the skin. The investigators will thoroughly evaluate the skin where the patches are applied.

Official Title

Phase Ib/II Study of Micro-needle Array Containing Doxorubicin in Immune Competent or Immune-suppressed Patients With Cutaneous Squamous Cell Carcinoma

Quick Facts

Study Start:2023-09-13

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05377905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subjects must have a histological diagnosis of cSCC based upon a skin biopsy. 2. Subjects must have resectable stage I-III disease. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 4. Subjects must have an expected survival of greater than or equal to 12 months. 5. Subjects must not be on any other investigational device/drug treatment. 6. Subjects must be willing to adhere to the instructions of the Investigator and his research team and sign an Informed Consent Form prior to entry into the study. 7. Subjects must have the following pretreatment laboratory parameters: granulocytes ≥1,500/mm3; platelets \>50,000/mm3; serum creatinine ≤2X the upper limit of normal (ULN); AST, ALT ≤3X the ULN, bilirubin ≤1.5X ULN unless Gilbert's disease then ≤3X ULN. 8. Subjects must be at least 18 years of age and must be able to understand the written informed consent/assent document. 9. Subjects must have no evidence of active infection, regardless of the degree of severity or localization. Subjects with active infections (whether or not they require antibiotic therapy) may be eligible for study participation after complete resolution of the infection. Subjects on antibiotic therapy must be off antibiotics before beginning treatment. 10. Subjects must not receive any other treatment for cSCC except emollients of subject's choice without topical steroids, anti-fungal or antibacterial topical preparations. 11. Subjects with multiple cSCC may re-enroll in the study if greater than 4 weeks elapses between courses and if all other inclusion/exclusion criteria are met. 12. Patients with HIV infection with CD4+ T-cell (CD4+) counts ≥ 350 cells/uL will be eligible for the study. Patients without a history of AIDS-defining opportunistic infections will be eligible for the study. 13. Subjects must be willing/able to comply with standard of care measures for subjects with cSCC such as sun avoidance and sun protection.	1. Subjects with the following tumor characteristics: * \>4 mm depth; * Clark level IV; * perineural invasion, lymphovascular invasion; * primary site on the ear or non-glabrous lip; * location in the hands or feet; * large size: ≥10 mm on neck or pretibial area; ≥20 mm on trunk or extremities; * indistinct borders; * rapid growth; * recurrent lesion; * lesion in site of chronic inflammation or prior radiation therapy; * presence of neurologic symptoms; or • poorly differentiated, and aggressive histopathologic subtypes. 2. Subjects with uncontrolled pain that would preclude participation in the study. 3. Subjects who are pregnant or lactating. 4. Subjects who have sensitivity to drugs that provide local anesthesia. 5. Impaired cardiac function or clinically significant cardiac disease, including any of the following: * Symptomatic congestive heart failure requiring treatment * Clinically significant cardiac arrhythmia * Uncontrolled hypertension * Corrected QT interval (QTc) \>470 msec at Screening or congenital long QT syndrome * Acute myocardial infarction or unstable angina pectoris \< 3 months prior to the first dose * New York Heart Association Functional Class III or higher (i.e. marked limitation of physical activity due to symptoms, or unable to carry on any physical activity without discomfort) 6. Subjects with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix. 7. Active, known, or suspected autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy. 8. Major surgery within 2 weeks of the first dose of study agent 9. History of or current drug-induced interstitial lung disease or pneumonitis Grade ≥2 10. Subjects with the disease only on the face, skin folds, head, scalp, and genital area.

Inclusion Criteria

Exclusion Criteria

1. Subjects must have a histological diagnosis of cSCC based upon a skin biopsy.
2. Subjects must have resectable stage I-III disease.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
4. Subjects must have an expected survival of greater than or equal to 12 months.
5. Subjects must not be on any other investigational device/drug treatment.
6. Subjects must be willing to adhere to the instructions of the Investigator and his research team and sign an Informed Consent Form prior to entry into the study.
7. Subjects must have the following pretreatment laboratory parameters: granulocytes ≥1,500/mm3; platelets \>50,000/mm3; serum creatinine ≤2X the upper limit of normal (ULN); AST, ALT ≤3X the ULN, bilirubin ≤1.5X ULN unless Gilbert's disease then ≤3X ULN.
8. Subjects must be at least 18 years of age and must be able to understand the written informed consent/assent document.
9. Subjects must have no evidence of active infection, regardless of the degree of severity or localization. Subjects with active infections (whether or not they require antibiotic therapy) may be eligible for study participation after complete resolution of the infection. Subjects on antibiotic therapy must be off antibiotics before beginning treatment.
10. Subjects must not receive any other treatment for cSCC except emollients of subject's choice without topical steroids, anti-fungal or antibacterial topical preparations.
11. Subjects with multiple cSCC may re-enroll in the study if greater than 4 weeks elapses between courses and if all other inclusion/exclusion criteria are met.
12. Patients with HIV infection with CD4+ T-cell (CD4+) counts ≥ 350 cells/uL will be eligible for the study. Patients without a history of AIDS-defining opportunistic infections will be eligible for the study.
13. Subjects must be willing/able to comply with standard of care measures for subjects with cSCC such as sun avoidance and sun protection.

1. Subjects with the following tumor characteristics:
* \>4 mm depth;
* Clark level IV;
* perineural invasion, lymphovascular invasion;
* primary site on the ear or non-glabrous lip;
* location in the hands or feet;
* large size: ≥10 mm on neck or pretibial area; ≥20 mm on trunk or extremities;
* indistinct borders;
* rapid growth;
* recurrent lesion;
* lesion in site of chronic inflammation or prior radiation therapy;
* presence of neurologic symptoms; or • poorly differentiated, and aggressive histopathologic subtypes.
2. Subjects with uncontrolled pain that would preclude participation in the study.
3. Subjects who are pregnant or lactating.
4. Subjects who have sensitivity to drugs that provide local anesthesia.
5. Impaired cardiac function or clinically significant cardiac disease, including any of the following:
* Symptomatic congestive heart failure requiring treatment
* Clinically significant cardiac arrhythmia
* Uncontrolled hypertension
* Corrected QT interval (QTc) \>470 msec at Screening or congenital long QT syndrome
* Acute myocardial infarction or unstable angina pectoris \< 3 months prior to the first dose
* New York Heart Association Functional Class III or higher (i.e. marked limitation of physical activity due to symptoms, or unable to carry on any physical activity without discomfort)
6. Subjects with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix.
7. Active, known, or suspected autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
8. Major surgery within 2 weeks of the first dose of study agent
9. History of or current drug-induced interstitial lung disease or pneumonitis Grade ≥2
10. Subjects with the disease only on the face, skin folds, head, scalp, and genital area.

Contacts and Locations

Study Contact

Charity L Ruhl, LPN

CONTACT

1-412-647-2013

ruhlcl@upmc.edu

Nicolena Verardi

CONTACT

1-412-864-3682

verardin3@upmc.edu

Principal Investigator

Oleg E Akilov, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Falo, Louis, MD

Oleg E Akilov, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-13

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-09-13

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

micro-needle array
doxorubicin
patch

Additional Relevant MeSH Terms

Cutaneous Squamous Cell Carcinoma
Skin Cancers - Squamous Cell Carcinoma