Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma
Basal Cell Carcinoma, Basal Cell Nevus Syndrome
About this trial
This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring Vitamin D, Photodynamic Therapy
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Basal Cell Nevus Syndrome (BCNS) as defined in the Consensus Statement from the first International colloquium on BCNS.
Major Criteria are:
- (1) BCC prior to age 20 years, or excessive number of BCCs out of proportion to prior sun exposure and skin type;
- (2) keratocyst of the jaw prior to age 20;
- (3) palmar or plantar pitting;
- (4) lamellar calcification of the falx cerebri;
- (5) medulloblastoma;
- (6) first degree relative with BCNS;
- (7) Patched-1 (PTCH1) gene mutation.
Minor Criteria are:
- (1) rib anomalies, or other specific skeletal malformations including kyphoscoliosis and short 4th metacarpals;
- (2) macrocephaly;
- (3) cleft/lip or palate;
- (4) fibroma of the heart or ovary;
- (5) ocular abnormalities;
- For diagnosis of BCNS, the participant must have either 2 major criteria, one major and two minor criteria.
- 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 3 months prior to visit 1.
- Taking any topical treatment on their BCC tumors; must stop at least 1 month prior.
- Taking Vitamin D or multivitamin supplements; must stop at least 1 month prior.
- Currently undergoing treatment for other cancers with medical or radiation therapy.
- Participants with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material.
- Participants with history of a photosensitivity disease, such as porphyria cutanea tarda.
- Currently participating in another clinical trial.
Sites / Locations
- Medical Dermatology Specialists PhoenixRecruiting
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group A: D3 prior to first PDT
Group B: D3 prior to second PDT visit
In both groups, one PDT session is preceded by neoadjuvant PDT while the other PDT session has no pretreatment. Group A will take dietary D3 pills prior to the first PDT treatment (day 1), and placebo pills prior to the second PDT treatment (at 2 months). Both Group A and Group B will take continuous serum D3 prior to the third PDT visit (Month 4). A final assessment of lesion clearance will be performed at 6 months
In both groups, one PDT session is preceded by neoadjuvant PDT while the other PDT session has no pretreatment. Group B will receive placebo prior to their first PDT visit (day 1), and Vitamin D3 prior to their second PDT visit (at 2 months). Both Group A and Group B will take continuous D3 prior to the third PDT visit (Month 4). A final assessment of lesion clearance will be performed at 6 months