Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC) (NCT05377905) | Clinical Trial Compass
RecruitingPhase 1/2
Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)
United States48 participantsStarted 2023-09-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
What they're measuring
1
Number of adverse events grade 2 or higher to evaluate safety of MNA-D patches in cSCC
2. 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.
✕3. 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:
✕. Subjects with uncontrolled pain that would preclude participation in the study.
✕. Subjects who are pregnant or lactating.
✕. Subjects who have sensitivity to drugs that provide local anesthesia.
✕. Impaired cardiac function or clinically significant cardiac disease, including any of the following:
✕. Subjects with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix.