Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFalo, Louis, MD
About this trial
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
Qualifiers
Subjects must have a histological diagnosis of cSCC based upon a skin biopsy.
Subjects must have resectable stage I-III disease.
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.
Disqualifiers
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.
>4 mm depth;
Clark level IV;
Trial design
Treatments tested in this trial
- Microneedle Array Doxorubicin (MNA-D)
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
Falo, Louis, MD
Lead sponsor
University of Pittsburgh
Sponsor institution
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov