Microneedle patches delivering doxorubicin for skin cancer treatment

Phase Ib/II Study of Micro-needle Array Containing Doxorubicin in Immune Competent or Immune-suppressed Patients With Cutaneous Squamous Cell Carcinoma

This study is testing a new way to treat skin cancer by using tiny microneedle patches to deliver a cancer-fighting drug directly to the tumor, focusing on both healthy and immunocompromised patients.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Drugs / interventions: radiation, chemotherapy, doxorubicin
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT05377905 on ClinicalTrials.gov

What this trial studies

This study evaluates a novel treatment for cutaneous squamous cell carcinoma (cSCC) using microneedle arrays (MNAs) that deliver low doses of doxorubicin directly to the tumor site. The approach aims to minimize systemic toxicity while effectively targeting cancer cells. Participants will be divided into two groups based on their immune status: immunocompetent patients and those who are immunoincompetent due to organ transplants. The study will assess both the safety and effectiveness of this localized chemotherapy method.

Who should consider this trial

Good fit: Ideal candidates include adults with a histological diagnosis of resectable stage I-III cutaneous squamous cell carcinoma.

Not a fit: Patients with non-resectable cSCC or those currently receiving other investigational treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective option for patients with cutaneous squamous cell carcinoma.

How similar studies have performed: While the use of microneedle technology in drug delivery is promising, this specific application with doxorubicin for cSCC is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

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.
13. Subjects must be willing/able to comply with standard of care measures for subjects with cSCC such as sun avoidance and sun protection.

Exclusion Criteria:

1. Subjects with the following tumor characteristics:

   * \>4 mm depth;
   * Clark level IV;
   * perineural invasion, lymphovascular invasion;
   * primary site on the ear or non-glabrous lip;
   * location in the hands or feet;
   * large size: ≥10 mm on neck or pretibial area; ≥20 mm on trunk or extremities;
   * indistinct borders;
   * rapid growth;
   * recurrent lesion;
   * lesion in site of chronic inflammation or prior radiation therapy;
   * presence of neurologic symptoms; or • poorly differentiated, and aggressive histopathologic subtypes.
2. Subjects with uncontrolled pain that would preclude participation in the study.
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
10. Subjects with the disease only on the face, skin folds, head, scalp, and genital area.

Where this trial is running

Pittsburgh, Pennsylvania

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Oleg E Akilov, MD, PhD — University of Pittsburgh
• Study coordinator: Charity L Ruhl, LPN

Conditions Cutaneous Squamous Cell Carcinoma; Skin Cancers - Squamous Cell Carcinoma; micro-needle array; doxorubicin; patch