CivaDerm for Skin Cancer

Overseen By Carra Castagnero

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: CivaTech Oncology

Disqualifiers: Pregnant, Breastfeeding, Metastases

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a pilot study to determine the usefulness of new brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit basal cell and squamous cell carcinoma patients by providing conformal radiation therapy to the surface of the skin.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

How does the CivaDerm treatment differ from other skin cancer treatments?

CivaDerm Surface Therapy is unique because it may involve a novel technological approach rather than new molecules, potentially offering a non-invasive alternative to traditional surgical methods for skin cancer treatment. ^{1 2 3 4 5}

Who Is on the Research Team?

Andrea Colton, MD

Principal Investigator

Clearly Derm

Are You a Good Fit for This Trial?

This trial is for individuals with confirmed superficial or nodular basal cell or squamous cell carcinoma. Tumors must be less than 3 cm and have at least a 5 mm residual tumor. Participants need to provide consent, have their cancer biopsied on the trunk or extremities, and follow patient release instructions.

Inclusion Criteria

My tumor is smaller than 3 cm but has some remaining parts after treatment.

subject signed informed consent

I have been diagnosed with basal cell or squamous cell skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Radioactive bandage applied to surface of the body worn for approximately one week

1 week

Follow-up

Participants are monitored for skin toxicity events and radiation dose delivery

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CivaDerm(TM) Surface Therapy

Trial Overview The study is testing CivaDerm, a new brachytherapy device using palladium-103 in a unique way to deliver targeted radiation therapy directly to skin cancers like basal and squamous cell carcinomas.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Radioactive bandage applied to surface of the body worn for approximately one week.

Who Is Running the Clinical Trial?

CivaTech Oncology

Lead Sponsor

Trials

7

Recruited

310+

Published Research Related to This Trial

Skin cancers are the most common type of cancer, especially among white populations, highlighting the urgent need for diverse treatment options beyond traditional surgery.

This paper reviews current therapies and emphasizes the potential of innovative technologies, such as nanotechnology and immunotherapy, to improve treatment outcomes for skin cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin cancer and new treatment perspectives: a review. Simões, MCF., Sousa, JJS., Pais, AACC.[2018]

Immunotherapy, particularly the use of topical immune response modifiers like imiquimod, shows promising effects in treating nonmelanoma skin cancer, which is the most common cancer type in humans.

Various immunotherapeutic strategies, including adoptive T-cell therapies and vaccines, are being explored to enhance the immune system's ability to combat nonmelanoma skin cancer, especially in cases of recurrent or multiple tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy in nonmelanoma skin cancer. Ghafouri-Fard, S., Ghafouri-Fard, S.[2022]

Recent advancements in melanoma treatment have significantly improved overall survival rates, highlighting the need for effective chemoprevention strategies to reduce the burden of metastatic disease.

The Melanoma Prevention Working Group is actively exploring and proposing new and repurposed drugs for melanoma prevention, assessing their mechanisms of action and clinical trial data to identify promising candidates for future phase 3 trials within the next 5 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemoprevention agents for melanoma: A path forward into phase 3 clinical trials. Jeter, JM., Bowles, TL., Curiel-Lewandrowski, C., et al.[2020]

Topical treatments like imiquimod and diclofenac with hyaluronic acid are effective non-invasive options for treating skin cancers such as basal and squamous cell carcinoma.

Photochemical internalisation (PCI), a refined form of photodynamic therapy, is currently being tested in clinical trials for various cancers, and early results indicate it may be a promising treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Photochemical internalisation (PCI): a further development of photodynamic therapy for the treatment of skin cancer]. Johansen, P., Berg, K., Selbo, PK., et al.[2010]

Simvastatin, when delivered through innovative chitosan-coated nanostructured lipid carriers (Ch-NLC), shows increased cytotoxicity against melanoma cells, suggesting its potential as a supportive treatment alongside existing melanoma therapies.

The developed topical films demonstrated sustained drug release, were classified as nonirritant, and effectively enhanced skin permeation, indicating their safety and efficacy for treating melanoma skin lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid Nanostructured Films for Topical Administration of Simvastatin as Coadjuvant Treatment of Melanoma. Barone, A., Mendes, M., Cabral, C., et al.[2023]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Skin cancer and new treatment perspectives: a review. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Immunotherapy in nonmelanoma skin cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Chemoprevention agents for melanoma: A path forward into phase 3 clinical trials. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Photochemical internalisation (PCI): a further development of photodynamic therapy for the treatment of skin cancer]. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Hybrid Nanostructured Films for Topical Administration of Simvastatin as Coadjuvant Treatment of Melanoma. [2023]