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Anti-tumor antibiotic

Microneedle Chemotherapy for Skin Cancer (cSCC Trial)

Q: Are we still enrolling individuals for this research project?

<p>No, this specific trial is not currently recruiting patients according to the latest information posted on clinicaltrials.gov. The study was first made public on November 15th, 2022 and has not been updated since November 2nd of the same year. Although this particular trial isn't looking for candidates, there are 2790 other trials that are still recruiting patients.</p>

Phase 1 & 2

Recruiting

Led By Oleg E Akilov, MD, PhD

Research Sponsored by Falo, Louis, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2

Subjects must have resectable stage I-III disease with measures ≥5 mm and <100 mm in longest diameter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up follow up period (weeks 5-8)

Awards & highlights

cSCC Trial Summary

This trial is testing a new way to treat skin cancer with a patch that has very small needles loaded with a low dose of chemotherapy. The goal is to see if it is safe and effective.

Who is the study for?

This trial is for adults with a confirmed diagnosis of cutaneous squamous cell skin cancer, which can be surgically removed and measures between 5mm to less than 100mm. Participants should have an ECOG status of 0-2, meaning they are fully active or at least capable of self-care, not on other experimental treatments, and able to follow study instructions. Pregnant individuals or those with significant heart issues, autoimmune diseases (with some exceptions), recent major surgery, lung conditions caused by drugs, or active infections like HIV/hepatitis cannot join.Check my eligibility

What is being tested?

The trial tests a new treatment using patches with tiny needles that deliver low doses of doxorubicin directly into the skin cancer area. The highest safe dose has been determined previously; now researchers want to see how effective this method is in treating skin cancer while monitoring safety closely.See study design

What are the potential side effects?

Potential side effects may include local reactions where the patch is applied such as redness or pain. Doxorubicin can cause hair loss, nausea/vomiting, mouth sores and could potentially affect blood counts leading to increased risk of infection or bleeding.

cSCC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

My cancer is in stages I-III and can be surgically removed.

Select...

I am over 18 and can understand the consent form.

Select...

My CD4+ count is 350 or higher and I have HIV.

Select...

My skin cancer diagnosis was confirmed by a biopsy.

Select...

I am not using any treatments for cSCC except for moisturizers without steroids or anti-fungal/antibacterial agents.

Select...

I do not have any current infections.

cSCC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ follow up period (weeks 5-8)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~follow up period (weeks 5-8)

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow up period (weeks 5-8) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of adverse events grade 2 or higher to evaluate safety of MNA-D patches in cSCC

Secondary outcome measures

Change from baseline of local response to the MNA-D patch

Flow cytometry quantitative biologic response evaluation in blood

Flow cytometry quantitative biologic response evaluation in tumor tissue

+7 more

cSCC Trial Design

1Treatment groups

Experimental Treatment

Group I: Microneedle Array Doxorubicin (MNA-D)Experimental Treatment1 Intervention

Immunocompetent and immuno-incompetent subjects will receive the MNA-D patch on 4 subsequent visits for a 20 minute time period at each application and will include patients who have competent immune systems with cSCC meeting all other inclusion/exclusion criteria and patients considered immuno-incompetent post transplant with cSCC meeting all other inclusion/exclusion criteria.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Falo, Louis, MDLead Sponsor

1 Previous Clinical Trials

20 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,926,085 Total Patients Enrolled

Oleg E Akilov, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh

3 Previous Clinical Trials

81 Total Patients Enrolled

Media Library

Doxorubicin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05377905 — Phase 1 & 2

Squamous Cell Carcinoma Research Study Groups: Microneedle Array Doxorubicin (MNA-D)

Squamous Cell Carcinoma Clinical Trial 2023: Doxorubicin Highlights & Side Effects. Trial Name: NCT05377905 — Phase 1 & 2

Doxorubicin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05377905 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still enrolling individuals for this research project?

"No, this specific trial is not currently recruiting patients according to the latest information posted on clinicaltrials.gov. The study was first made public on November 15th, 2022 and has not been updated since November 2nd of the same year. Although this particular trial isn't looking for candidates, there are 2790 other trials that are still recruiting patients."

Answered by AI

Recent research and studies

Journal of the American Academy of DermatologyJournal

Cutaneous Squamous Cell Carcinoma: Estimated Incidence of Disease, Nodal Metastasis, and Deaths from Disease in the United States, 2012

Karia, Pritesh S., Jiali Han, and Chrysalyne D. Schmults. 2013. “Cutaneous Squamous Cell Carcinoma: Estimated Incidence of Disease, Nodal Metastasis, and Deaths from Disease in the United States, 2012”. Journal of the American Academy of Dermatology. Elsevier BV. doi:10.1016/j.jaad.2012.11.037.

Clinical Cancer ResearchJournal

Genomic Analysis of Metastatic Cutaneous Squamous Cell Carcinoma

Li, Yvonne Y., Glenn J. Hanna, Alvaro C. Laga, Robert I. Haddad, Jochen H. Lorch, and Peter S. Hammerman. 2015. “Genomic Analysis of Metastatic Cutaneous Squamous Cell Carcinoma”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-14-1773.

American Journal of TransplantationJournal

The Cutting Edge of Skin Cancer in Transplant Recipients: Scientific Retreat of International Transplant Skin Cancer Collaborative and Skin Cancer in Organ Transplant Patients Europe

Hanlon, A., and O. R. Colegio. 2014. “The Cutting Edge of Skin Cancer in Transplant Recipients: Scientific Retreat of International Transplant Skin Cancer Collaborative and Skin Cancer in Organ Transplant Patients Europe”. American Journal of Transplantation. Wiley. doi:10.1111/ajt.12681.

The LancetJournal