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

NCT05377905 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY210901231P50CA254865-01A1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cutaneous Squamous Cell Carcinoma; Skin Cancers - Squamous Cell Carcinoma

Keywords

micro-needle array; doxorubicin; patch

Outcome Measures

Primary Outcomes (1)

• Number of adverse events grade 2 or higher to evaluate safety of MNA-D patches in cSCC

  Evaluated by assessing adverse events grade 2 or higher related to the MNA-D intervention

  Baseline up to week 8

Secondary Outcomes (10)

• Change from baseline of local response to the MNA-D patch

  Baseline and follow up (weeks 5-8)

• Tumor clearance from baseline of locoregional (total area of the index lesion) response to the MNA-D Patch

  Baseline and follow up (weeks 5-8)

• Quantitative pathologic evaluation of tumor depth

  Follow up period (weeks 5-8)

• Flow cytometry quantitative biologic response evaluation in blood

  Baseline and follow up (weeks 5-8)

• Flow cytometry quantitative biologic response evaluation in tumor tissue

  Baseline and follow up (weeks 5-8)

Study Arms (1)

Microneedle Array Doxorubicin (MNA-D)

EXPERIMENTAL

Immunocompetent and immuno-incompetent subjects will receive the MNA-D patch on 4 subsequent visits for a 20 minute time period at each application and will include patients who have competent immune systems with cSCC meeting all other inclusion/exclusion criteria and patients considered immuno-incompetent post transplant with cSCC meeting all other inclusion/exclusion criteria.

Drug: Microneedle Array Doxorubicin (MNA-D)

Interventions

Microneedle Array Doxorubicin (MNA-D) DRUG

The Microneedle array patch is loaded/prepared with a total dose of 50 micrograms of Doxorubicin and is applied to a single selected cSCC remnant for a period of 20 minutes for a total of 4 weekly applications

Also known as: MNA-D, Doxorubicin, Patch

Microneedle Array Doxorubicin (MNA-D)

Eligibility Criteria

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

You may qualify if:

• Subjects must have a histological diagnosis of cSCC based upon a skin biopsy.
• Subjects must have resectable stage I-III disease.
• \- Measures ≥5 millimeters (mm; post-biopsy) and \<100 mm in longest diameter
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
• Subjects must have an expected survival of greater than or equal to 12 months.
• Subjects must not be on any other investigational device/drug treatment.
• 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.
• 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.
• Subjects must be at least 18 years of age and must be able to understand the written informed consent/assent document.
• 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.
• Subjects must not receive any other treatment for cSCC except emollients of subject's choice without topical steroids, anti-fungal or antibacterial topical preparations.

You may not qualify if:

• 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.
• Subjects must be willing/able to comply with standard of care measures for subjects with cSCC such as sun avoidance and sun protection.
• 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.
• Subjects with uncontrolled pain that would preclude participation in the study.

Sponsors & Collaborators

• Falo, Louis, MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (7)

• Madeleine MM, Patel NS, Plasmeijer EI, Engels EA, Bouwes Bavinck JN, Toland AE, Green AC; the Keratinocyte Carcinoma Consortium (KeraCon) Immunosuppression Working Group. Epidemiology of keratinocyte carcinomas after organ transplantation. Br J Dermatol. 2017 Nov;177(5):1208-1216. doi: 10.1111/bjd.15931. Epub 2017 Oct 10.

  PMID: 28994104 BACKGROUND

• Hanlon A, Colegio OR. The cutting edge of skin cancer in transplant recipients: scientific retreat of international transplant Skin Cancer Collaborative and Skin Cancer in Organ Transplant Patients Europe. Am J Transplant. 2014 May;14(5):1012-5. doi: 10.1111/ajt.12681. Epub 2014 Mar 10.

  PMID: 24612476 BACKGROUND

• Karia PS, Han J, Schmults CD. Cutaneous squamous cell carcinoma: estimated incidence of disease, nodal metastasis, and deaths from disease in the United States, 2012. J Am Acad Dermatol. 2013 Jun;68(6):957-66. doi: 10.1016/j.jaad.2012.11.037. Epub 2013 Feb 1.

  PMID: 23375456 BACKGROUND

• Li YY, Hanna GJ, Laga AC, Haddad RI, Lorch JH, Hammerman PS. Genomic analysis of metastatic cutaneous squamous cell carcinoma. Clin Cancer Res. 2015 Mar 15;21(6):1447-56. doi: 10.1158/1078-0432.CCR-14-1773. Epub 2015 Jan 14.

  PMID: 25589618 BACKGROUND

• Freeman A, Bridge JA, Maruthayanar P, Overgaard NH, Jung JW, Simpson F, Prow TW, Soyer HP, Frazer IH, Freeman M, Wells JW. Comparative immune phenotypic analysis of cutaneous Squamous Cell Carcinoma and Intraepidermal Carcinoma in immune-competent individuals: proportional representation of CD8+ T-cells but not FoxP3+ Regulatory T-cells is associated with disease stage. PLoS One. 2014 Oct 23;9(10):e110928. doi: 10.1371/journal.pone.0110928. eCollection 2014.

  PMID: 25340823 BACKGROUND

• Farasat S, Yu SS, Neel VA, Nehal KS, Lardaro T, Mihm MC, Byrd DR, Balch CM, Califano JA, Chuang AY, Sharfman WH, Shah JP, Nghiem P, Otley CC, Tufaro AP, Johnson TM, Sober AJ, Liegeois NJ. A new American Joint Committee on Cancer staging system for cutaneous squamous cell carcinoma: creation and rationale for inclusion of tumor (T) characteristics. J Am Acad Dermatol. 2011 Jun;64(6):1051-9. doi: 10.1016/j.jaad.2010.08.033. Epub 2011 Jan 20.

  PMID: 21255868 BACKGROUND

• Madan V, Lear JT, Szeimies RM. Non-melanoma skin cancer. Lancet. 2010 Feb 20;375(9715):673-85. doi: 10.1016/S0140-6736(09)61196-X.

  PMID: 20171403 BACKGROUND

MeSH Terms

Interventions

Doxorubicin; Transdermal Patch

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Equipment and Supplies

Study Officials

• Oleg E Akilov, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charity L Ruhl, LPN

CONTACT

1-412-647-2013; ruhlcl@upmc.edu

Nicolena Verardi

CONTACT

1-412-864-3682; verardin3@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is an open-label, comparative 2-cohort design

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 17, 2022
• Study Start: September 13, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)