Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Falo, Louis, MD
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

1. Subjects must have a histological or cytological 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 to12 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 ³ 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.

Exclusion Criteria:

1. Subjects with uncontrolled pain that would preclude participation in the study.

2. Subjects with known active HIV, and/or hepatitis infection.

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

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