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New treatment option for Cutaneous Squamous Cell Carcinoma
Official title Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)
ClinicalTrials.gov ID: NCT05377905
What this study is testing
What is Microneedle Array Doxorubicin (MNA-D)?
Microneedle Array Doxorubicin (MNA-D) is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for cutaneous squamous cell carcinoma.
Also referred to as MNA-D, Doxorubicin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must have a histological diagnosis of cSCC based upon a skin biopsy.
- people 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
- people must have an expected survival of greater than or equal to 12 months.
- people must not be on any other investigational device/drug treatment.
You likely can't join if
- are met.
- 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...
- people must be willing/able to comply with standard of care measures for people with cSCC such as sun avoidance and sun protection. Exclusion...
- people with the following tumor characteristics:
- \>4 mm depth;
- Clark level IV;
See the full eligibility criteria
- people must have a histological diagnosis of cSCC based upon a skin biopsy.
- people 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
- people must have an expected survival of greater than or equal to 12 months.
- people must not be on any other investigational device/drug treatment.
- people 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.
- people 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...
- people must be at least 18 years of age and must be able to understand the written informed consent/assent document.
- people must have no evidence of active infection, regardless of the degree of severity or localization. people with active infections (whether or not they require antibiotic therapy) may be eligible for study...
- people must not receive any other treatment for cSCC except emollients of subject's choice without topical steroids, anti-fungal or antibacterial topical preparations.
- people with multiple cSCC may re-enroll in the study if greater than 4 weeks elapses between courses and if all other inclusion/
- are met.
- 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.
- people must be willing/able to comply with standard of care measures for people with cSCC such as sun avoidance and sun protection. Exclusion Criteria:
- people 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.
- people with uncontrolled pain that would preclude participation in the study.
- people who are pregnant or lactating.
- people 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)
- people 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...
- 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
- people with the disease only on the face, skin folds, head, scalp, and genital area.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.