Pittsburgh, PANCT05377905Now EnrollingIRB Ready

Cutaneous Squamous Cell Carcinoma Clinical Trial in Pittsburgh, PA

Access cutting-edge cutaneous squamous cell carcinoma treatment through this clinical trial at a research site in Pittsburgh. Study-provided care at no cost to qualified participants.

Sponsored by Falo, Louis, MD

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Expert Care in Pittsburgh

Access cutaneous squamous cell carcinoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related cutaneous squamous cell carcinoma treatment provided free

Apply for This Pittsburgh Location

Check if you qualify for this cutaneous squamous cell carcinoma clinical trial in Pittsburgh, PA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Pittsburgh

    Convenient for PA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Pittsburgh site if eligible
  4. 4Begin participation

About This Cutaneous Squamous Cell Carcinoma Study in Pittsburgh

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.

Sponsor: Falo, Louis, MD

Who Can Participate

Inclusion Criteria

Subjects must have a histological diagnosis of cSCC based upon a skin biopsy.
Subjects must have resectable stage I-III disease. \- Measures ≥5 millimeters (mm; post-biopsy) and \<100 mm in longest diameter
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.
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.
Subjects must not receive any other treatment for cSCC except emollients of subject's choice without topical steroids, anti-fungal or antibacterial topical preparations.
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

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. Exclusion Criteria:
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.
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:
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)
Subjects with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix.
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.
Major surgery within 2 weeks of the first dose of study agent
History of or current drug-induced interstitial lung disease or pneumonitis Grade ≥2
Subjects with the disease only on the face, skin folds, head, scalp, and genital area.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Pittsburgh?

Yes, this clinical trial (NCT05377905) has an active research site in Pittsburgh, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cutaneous Squamous Cell Carcinoma Treatment Options in Pittsburgh, PA

If you're searching for cutaneous squamous cell carcinoma treatment options in Pittsburgh, PA, this clinical trial (NCT05377905) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Pittsburgh research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cutaneous squamous cell carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

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Secure · Expert Care · Pittsburgh, PA