Gene therapy to reduce skin cancer recurrence in patients with a specific genetic condition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of BVEC-induced COL7A1 gene therapy in patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB) who have undergone excision of Squamous Cell Carcinoma (SCC). The therapy is designed to normalize the tumor microenvironment, potentially reducing the likelihood of cancer recurrence. Participants will be monitored for changes in tumor behavior and overall skin health following treatment. The study is interventional and is currently in Phase 2.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations
2. Presence of biopsy proven squamous cell carcinoma (SCC)
3. Ability to understand and the willingness to provide written informed consent.
4. US based participants are willing to use beremagene geperpavec (BVEC)
5. Subject is 18 years or older
6. participant willingness to use an effective method of contraception

Exclusion Criteria:

1. Inability to travel to site for study visit
2. Subject is pregnant
3. Subject has Metastatic SCC's or is on any current systemic treatment for SCC.

Where it's running

• Stanford University
  Redwood City, California, United States Recruiting
• Azienda Ospedliero-Universitaia
  Bari, Italy Recruiting

Study contacts

• Principal investigator: Peter Marinkovich, MD — Stanford University
• Study coordinator: Kunju Sridhar
• Email: kunju@stanford.edu
• Phone: 650-721-4902

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Safe use of metformin and naproxen to help prevent cancer in people with Fanconi anemia

  This study tests whether metformin and naproxen can lower the chance of cancer developing in adults with Fanconi anemia.

  Recruiting at 2 sites Phase 1 Rockefeller University · Minneapolis, Minnesota and 1 other locations · NCT07901959

• Two-photon microscopy on skin biopsies to help diagnose skin lesions

  This study tests whether images from two-photon fluorescence microscopy of dermatology biopsies can match the diagnosis determined by standard histology.

  Recruiting University of Rochester · Victor, New York · NCT07773688

• Targeted dual-imaging helper for head and neck cancer surgery

  This study tests whether using two imaging agents during surgery can help doctors see tumors and cancerous lymph nodes in adults with head and neck squamous cell carcinoma.

  Recruiting Phase 1 Vanderbilt-Ingram Cancer Center · Nashville, Tennessee · NCT07741643

• Methionine-Reduced Diet in Solid Tumors (early-phase)

  A small pilot study will test whether a methionine-reduced diet can change blood levels in adults with various solid tumors who are receiving standard cancer therapy.

  Recruiting Early Phase 1 University of California, Irvine · Orange, California · NCT07628634

• IDP-001 in advanced or metastatic solid tumors (including head and neck and skin cancers)

  A first- and second-phase study will test IDP-001 in people with advanced or metastatic solid tumors to see if it is safe and tolerable and to look for signs of activity.

  Recruiting at 6 sites Phase 1/2 InduPro, Inc. · Los Angeles, California and 5 other locations · NCT07602842

• Omitting postoperative radiation after HPV-related oropharyngeal cancer guided by ctHPVDNA monitoring

  This study tests whether some patients with HPV-related OPSCC can skip postoperative radiation after surgery if their tumors are low risk and ctHPVDNA looks negative.

  Recruiting Phase 2 Medical University of South Carolina · Charleston, South Carolina · NCT07513389

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.