Vitamin D and Photodynamic Therapy for Treatment of BCC in BCNS

  • STATUS
    Recruiting
  • days left to enroll
    89
  • participants needed
    50
  • sponsor
    The Cleveland Clinic
Updated on 27 January 2021
cancer
photodynamic therapy
carcinoma
cholecalciferol
skin cancer
vitamin d
basal cell nevus syndrome
nevus
multiple basal cell carcinoma

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.

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.

Details
Condition Basal cell carcinoma, Hereditary Neoplastic Syndrome, Hereditary Cancer Syndromes, Basal Cell Nevus Syndrome, Hereditary Cancer Syndromes, basal cell carcinomas, basal cell carcinoma of skin
Treatment Vitamin D, Placebo Pill, PDT
Clinical Study IdentifierNCT03483441
SponsorThe Cleveland Clinic
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

A diagnosis of Basal Cell Nevus Syndrome (BCNS)
At least three BCC tumors (two of which are biopsy-proven)
Female subjects must not become pregnant during the study
Subjects must be able to understand and willing to sign a written informed consent document

Exclusion Criteria

Pregnant or nursing
At risk for hypercalcemia (renal disease, sarcoidosis, etc.)
Taking vismodegib or a hedgehog pathway inhibitor; must stop at least 1 month prior
Taking any topical treatment on their BCC tumors; must stop at least one month prior
Taking Vitamin D or multivitamin supplements; must stop at least one month prior
Currently undergoing treatment for other cancers with medical or radiation therapy
Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material
Patients with history of a photosensitivity disease, such as porphyria cutanea tarda
Currently participating in another clinical trial
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