Vitamin D Given before Photodynamic Therapy When Treating Patients with Basal Cell Cancer in Basal Cell Nevus Syndrome

Inclusion Criteria

• A diagnosis of basal cell nevus syndrome (BCNS) as defined in the consensus statement from the first International Colloquium on BCNS.
• MAJOR CRITERIA:
• BCC prior to age 20 years, or excessive number of BCCs out of proportion to prior sun exposure and skin type.
• Keratocyst of the jaw prior to age 20.
• Palmar or plantar pitting.
• Lamellar calcification of the falx cerebri.
• Medulloblastoma.
• First degree relative with BCNS.
• PTCH1 gene mutation.
• MINOR CRITERIA:
• Rib anomalies, or other specific skeletal malformations including kyphoscolosis and short 4th metacarpals.
• Macrocephaly.
• Cleft/lip or palate.
• Fibroma of the heart or ovary.
• Ocular abnormalities.
• Other rare abnormalities listed in the article.
• For diagnosis of BCNS, the patient must have either 2 major criteria, one major and two minor criteria.
• At least three BCC tumors, two of which are biopsy-proven. Since BCNS patients tend to have a similar clinical pattern for all their tumors, biopsy of 2 lesions will provide a reasonable sampling to assure a proper diagnosis. To enhance our ability to reach the enrollment target, non-BCNS patients with multiple BCC tumors (patients without a diagnosis of BCNS, but with at least 3 BCC tumors present simultaneously) will also be eligible for this study. Histological confirmation of BCC in two of the clinically-diagnosed BCC lesions will be obtained, either at the enrollment/screening visit by performing skin biopsies that same day, or by obtaining the biopsy report if those lesions were biopsied elsewhere.
• Female subjects must not become pregnant during the study. The effects of 5-aminolevulinic acid (Levulan) on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (double barrier method of birth control or abstinence) prior to study entry, and for the duration of study participation. Should a woman become pregnant or suspect that she is pregnant while she is participating in this study, she should inform the treating physician immediately.
• 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 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.