Vitamin D and Photodynamic Therapy for Treatment of BCC in BCNS

Basal Cell Carcinoma Clinical Trial

Official title: Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma in Basal Cell Nevus Syndrome

Status Recruiting

Clinical Trial Summary

The purpose of this research is to evaluate the use of Photodynamic Therapy (PDT) to treat the multiple basal cell carcinoma (BCC) skin cancers in children and adults with Basal Cell Nevus Syndrome (or who have at least 3 BCC tumors present). In addition, the investigators will test a hypothesis (based upon our extensive preclinical studies in mice) that induction of a transient spike in serum Vitamin D levels through administration of dietary Vitamin D (cholecalciferol; D3) can significantly increase PDT efficacy and improve the clearance of cutaneous BCC tumors.

Clinical Trial Description

Patients with a rare genetic syndrome, called Basal Cell Nevus Syndrome or Gorlin-Goltz Syndrome (caused by a mutation in the PTCH1 gene) will be recruited to participate in this study. Potential patients will be referred by their local physicians or by the BCCNS Life Support Network to contact a study coordinator about enrollment.

The study will examine a combination regimen of Vitamin D3/PDT and compare its efficacy in treating BCC tumors to PDT alone. The hypothesis is that oral D3 supplements, administered over a relatively short time, can boost the effectiveness of PDT for cutaneous (BCC) in this patient population. Participants will receive three PDT treatments, at two-month intervals, over a 6 month period.

Tumor clinical clearance rates after neoadjuvant Vitamin D3/PDT, versus PDT alone, will be compared within the same patient. Measurement endpoints will include tumor dimensions by clinical examination, tumor measurements in photographs, PpIX fluorescence, serum 25OH-D3 levels, and characterization of VDR gene alleles. In addition, assessments of the tolerability (pain scale measurements) and patient satisfaction with the technique will be measured. ;

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Basal Cell Nevus Syndrome
• Carcinoma
• Carcinoma, Basal Cell
• Syndrome

• NCT number: NCT03483441
• Study type: Interventional
• Source: The Cleveland Clinic
• Contact: Jeff Negrey, MA
• Phone: 216-636-5504
• Email: negreyj2@ccf.org
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2018
• Completion date: May 1, 2023