Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC) (NCT05377905)

🧪 Interventions in This Study

• Microneedle Array Doxorubicin (MNA-D) (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania

📞 Contact the Study Coordinator

Phone: (412) 647-2013

Email: ruhlcl@upmc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Cutaneous Squamous Cell Carcinoma

• Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer — La Jolla, California
• Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma — Houston, Texas
• Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy — Boston, Massachusetts
• TIL Therapy in cSCC and MCC — Boston, Massachusetts
• A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma — Albury, New South Wales
• A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer — Aurora, Colorado

Explore by condition: All Cutaneous Squamous Cell Carcinoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.