NCT05377905 Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)
| NCT ID | NCT05377905 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Falo, Louis, MD |
| Condition | Cutaneous Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-09-13 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2023-09-13 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Subjects must have a histological diagnosis of cSCC based upon a skin biopsy. 2. Subjects must have resectable stage I-III disease. \- Measures ≥5 millimeters (mm; post-biopsy) and \<100 mm in longest diameter 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. Exclusion Criteria: 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. • Individuals with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, history of Hashimoto's thyroiditis on stable dose of thyroid hormone replacement therapy, adrenal insufficiency only requiring physiologic steroid replacement, or conditions not expected to recur should not be excluded. 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.
Contact & Investigator
Oleg E Akilov, MD, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05377905 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cutaneous Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05377905 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05377905 currently recruiting?
Yes, NCT05377905 is actively recruiting participants. Contact the research team at ruhlcl@upmc.edu for enrollment information.
Where is the NCT05377905 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT05377905 clinical trial?
NCT05377905 is sponsored by Falo, Louis, MD. The principal investigator is Oleg E Akilov, MD, PhD at University of Pittsburgh. The trial plans to enroll 48 participants.