Study on Microneedle Patches with Doxorubicin for Treating Skin Cancer

Sponsor: Falo, Louis, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05377905

Provider View

This clinical trial is testing a new treatment method for cutaneous squamous cell skin cancer using small patches with tiny needles that deliver low doses of the chemotherapy drug doxorubicin directly to the tumor. The study aims to evaluate the safety and effectiveness of these patches.

Patient Parameters

Program Overview

The study is exploring a new way to treat cutaneous squamous cell cancer (cSCC) using patches with tiny needles that dissolve and deliver a chemotherapy drug called doxorubicin directly to the cancer cells in the skin. This method aims to kill cancer cells and potentially trigger an immune response to help fight the cancer. The patches are designed to target the tumor directly, reducing the risk of side effects throughout the body. The study will include two groups: one with patients who have a normal immune system and another with patients who have had an organ transplant and have a weaker immune system. The treatment will involve applying the patches over several weeks, followed by a rest period and a final check-up to ensure the cancer is fully removed.

Description

This study is testing a new treatment for cutaneous squamous cell cancer (cSCC) using dissolvable microneedle patches that deliver a chemotherapy drug, doxorubicin, directly to the tumor. The goal is to kill cancer cells and possibly stimulate the immune system to fight the cancer. Doxorubicin is a well-known drug with a good safety record. The patches aim to deliver the drug directly to the tumor, minimizing side effects. The study will have two groups: one with patients who have a normal immune system and another with patients who have had an organ transplant and have a weaker immune system. The treatment involves applying the patches from week 0 to week 3, followed by a rest week, and a final follow-up visit by week 8 to ensure the cancer is fully removed.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of cutaneous squamous cell cancer (cSCC) from a skin biopsy.
  • Cancer must be in stage I-III and can be surgically removed.
  • Tumor size must be between 5 mm and 100 mm in the longest diameter after biopsy.
  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Expected to live for at least 12 more months.
  • Not currently receiving any other experimental treatments.
  • Willing to follow study instructions and sign a consent form.
  • Must meet specific blood test requirements for granulocytes, platelets, kidney, and liver function.
  • Must be 18 years or older and able to understand the consent form.
  • No active infections; any infections must be resolved before starting treatment.
  • Not receiving any other treatment for cSCC except moisturizers without steroids or antibiotics.
  • Can re-enroll if more than 4 weeks have passed between treatments and all criteria are met.
  • HIV-positive patients with CD4+ counts of 350 or higher and no history of AIDS-defining infections are eligible.
  • Must agree to follow standard care measures for cSCC, like avoiding sun exposure.

Exclusion Criteria

  • Tumors with certain characteristics, such as being deeper than 4 mm, having certain types of invasion, or being located in specific areas like the ear or lips.
  • Uncontrolled pain that would interfere with participation.
  • Pregnant or breastfeeding women.
  • Allergies to local anesthesia drugs.
  • Significant heart problems, such as heart failure or recent heart attack.
  • Other active cancers, except for non-metastatic prostate cancer and certain skin or cervical cancers.
  • Autoimmune diseases, except for conditions like vitiligo or controlled thyroid disorders.
  • Major surgery within 2 weeks before starting the study.
  • History of lung disease caused by drugs or pneumonitis.
  • Cancer located only on the face, skin folds, head, scalp, or genital area.

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