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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Microneedle Array Doxorubicin (MNA-D)
DrugThe 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
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Microneedle Array Doxorubicin (MNA-D)Experimental treatment 1 intervention
Trial outcomes
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
Time frame
Baseline up to week 8Secondary outcomes
1
Change from baseline of local response to the MNA-D patch
Percentage of tumor clearance of the area directly under the patch is measured..
Time frame
Baseline and follow up (weeks 5-8)2
Tumor clearance from baseline of locoregional (total area of the index lesion) response to the MNA-D Patch
Percentage of tumor clearance from the entire cSCC lesion treated by the patch is measured including the area directly covered by the MNA and uncovered area of the treated lesion. .
Time frame
Baseline and follow up (weeks 5-8)3
Quantitative pathologic evaluation of tumor depth
To provide a quantitative assessment of cSCC reduction after treatment, the remnant of cSCC tumors will be excised at week 5-8 and evaluated independently by 2 dermatopathologists in the blinded fashion. The depth of the cSCC will be measured.
Time frame
Follow up period (weeks 5-8)4
Flow cytometry quantitative biologic response evaluation in blood
Flow cytometry will evaluate in-vivo tumor immune responses in the blood and will analyze total immune activity for increases and/or decreases in T cell populations of interest and other immune cells (e.g., MDSCs, NK cells, B cells, macrophages, dendritic cells) that could influence the frequency and phenotype of these populations.
Time frame
Baseline and follow up (weeks 5-8)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Falo, Louis, MD
Lead sponsor
University of Pittsburgh
Sponsor institution
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov