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 trial tests a new treatment called CivaDerm, a special radioactive bandage, for certain types of skin cancer. It delivers radiation directly to the skin to treat basal cell and squamous cell carcinoma. The trial aims to determine the effectiveness of this method. Suitable participants have skin cancer on areas like the chest, back, or arms, with tumor sizes between 5 millimeters and 3 centimeters. Participants must be able to follow the treatment instructions. As an Early Phase 1 trial, this research focuses on understanding how CivaDerm works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

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.

What prior data suggests that this brachytherapy device is safe for skin cancer treatment?

Research is investigating the safety and effectiveness of CivaDerm(TM) Surface Therapy for treating skin cancers such as basal cell and squamous cell carcinoma. This treatment involves a special bandage containing a small amount of radiation, known as palladium-103, applied to the skin.

The FDA has approved CivaDerm for certain radiation treatments, indicating it has passed some safety checks for similar applications. However, this trial is among the first to test it specifically for skin cancer, aiming to determine if any side effects are manageable. As an early study, the primary focus is to identify any side effects and ensure patients tolerate the treatment well.

Currently, detailed information on side effects for this specific use is unavailable, but the treatment is based on technology generally considered safe. Participation in this study can help confirm its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for skin cancer involve surgical removal, radiation therapy, or topical chemotherapy. However, CivaDerm(TM) Surface Therapy stands out because it uses a radioactive bandage applied directly to the skin. This innovative delivery method allows the treatment to target cancer cells precisely while minimizing damage to surrounding healthy tissue. Researchers are excited about CivaDerm because it offers a non-invasive alternative that patients wear for about a week, potentially reducing recovery time and side effects compared to conventional treatments.

What evidence suggests that this brachytherapy device is effective for skin cancer?

Research has shown that CivaDerm Surface Therapy, which trial participants will receive, is under study for its potential to treat basal cell and squamous cell skin cancers. This therapy uses a new form of palladium-103, a radioactive material commonly used in cancer treatment, to target cancer cells on the skin's surface. Early results suggest that this method effectively delivers radiation directly to the affected area, potentially leading to better patient outcomes. While detailed results are still being gathered, the treatment aims to provide precise radiation delivery with manageable side effects. ^{1 2 6 7 8}

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/early-phase-1-carcinoma-7-2020-82252

CivaDerm for Skin Cancer ... Surface Therapy will have tolerable side effects & efficacy for patients with Skin Cancer, Basal Cell Carcinoma, Skin Cancer and Basal Cell Carcinoma. See if

2. trialx.com trialx.com/clinical-trials/listings/302354/civadermtm-surface-therapy-pilot-study/

CivaDerm(TM) Surface Therapy Pilot Study This is a pilot study to determine the usefulness of new brachytherapy device that utilizes active components (palladium-103) of standard ...

3. clinconnect.io clinconnect.io/conditions/squamous-cell-carcinoma-of-the-skin

Squamous Cell Carcinoma of the Skin - ClinConnect The CivaDerm(TM) Surface Therapy Pilot Study is looking at a new treatment ... This clinical trial is investigating the effectiveness of two treatments for ...

4. go.drugbank.com go.drugbank.com/conditions/DBCOND0168836

Cutaneous Squamous Cell Carcinoma (CSCC) ... CivaDerm(TM) Surface Therapy Pilot Study, No drug interventions, treatment, 1 ... NCT05574101. A Study of Radiation Therapy and Cemiplimab for People With Skin ...

5. synapse.patsnap.com synapse.patsnap.com/disease/e0009011a5d448d4884f0094b300e609

Superficial basal cell carcinoma - Drugs, Targets, Patents Early Phase 1. CivaDerm(TM) Surface Therapy Pilot Study ... trial outcomes, the efficacy rates for AK appear lower than expected. ... Skin Cancer. AIV001 is ...

6. civatechoncology.com civatechoncology.com/civaderm/

CivaDerm Cleared by the FDA for intraoperative and surface radiation · Starting 30 patient clinical study to determine outcomes for skin cancer over 6 ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0040396

Basal Cell Carcinoma (BCC) (DBCOND0040396) CivaDerm(TM) Surface Therapy Pilot Study, No drug interventions, treatment, 1 ... Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial.

8. clinicaloncologyonline.net clinicaloncologyonline.net/article/S0936-6555(22)00100-5/fulltext

Hypofractionated Radiation Therapy in Keratinocyte ... Hypofractionated radiation therapy regimens are well suited to the management of keratinocyte carcinomas. Most lesions are small, superficial and not close to ...