Actively Recruiting
Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)
Led by Falo, Louis, MD · Updated on 2026-04-09
48
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
Sponsors
F
Falo, Louis, MD
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of cutaneous squamous cell carcinoma confirmed by skin biopsy
- Resectable stage I to III disease with tumor size 5 millimeters and less than 100 millimeters in longest diameter
- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- Expected survival of at least 12 months
- Not receiving any other investigational drug or device treatments
- Willingness to follow investigator instructions and to sign informed consent
- Pretreatment lab values with granulocytes 1,500/mm3; platelets >50,000/mm3; serum creatinine 2 times upper limit of normal; AST, ALT 3 times upper limit of normal; bilirubin 1.5 times upper limit of normal (or up to 3 times for Gilbert's disease)
- At least 18 years of age and able to understand informed consent
- No active infections or infections completely resolved before treatment; off antibiotics
- No other treatments for cSCC except emollients without topical steroids, antifungal, or antibacterial preparations
- May re-enroll if multiple cSCC lesions with at least 4 weeks between treatments
- HIV patients with CD4+ count 350 cells/uL and no history of AIDS-defining infections
- Willing to comply with standard care including sun avoidance and protection
You will not qualify if you...
- Tumor characteristics including depth >4 mm, Clark level IV, perineural or lymphovascular invasion, specific locations (ear, non-glabrous lip, hands, feet), large size (>10 mm on neck or pretibial area; >20 mm on trunk or extremities), indistinct borders, rapid growth, recurrent lesion, lesions at sites of chronic inflammation or prior radiation, neurologic symptoms, or aggressive histopathologic subtypes
- Uncontrolled pain preventing study participation
- Pregnancy or lactation
- Sensitivity to local anesthesia drugs
- Significant heart problems including symptomatic heart failure, arrhythmia, uncontrolled hypertension, long QT interval, recent heart attack or unstable angina, or severe physical activity limitation
- Other active cancers except non-metastatic prostate cancer and carcinoma in situ of skin or cervix
- Active or history of autoimmune diseases except specific exceptions (vitiligo, resolved asthma/atopy, certain thyroid conditions, psoriasis not requiring systemic treatment, adrenal insufficiency with physiologic steroids)
- Major surgery within 2 weeks before first treatment dose
- History or current drug-induced lung disease or pneumonitis grade 2 or higher
- Disease only located on face, skin folds, head, scalp, or genital area
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
C
Charity L Ruhl, LPN
CONTACT
N
Nicolena Verardi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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