CompletedPhase 1

Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma

United States37 participantsStarted 2018-10-01

Plain-language summary

The purpose of this study is to study 50 patients with multiple Basal Cell Carcinoma (BCC) who will be receiving Photodynamic Therapy (PDT) as treatment for their tumors. This study wants to establish the optimal conditions for treating BCC tumors with PDT. Previous research suggests that taking Vitamin D prior to the start of PDT could help improve the effectiveness of the treatment in eliminating the BCC. Overall, this study will help establish oral Vitamin D3/PDT as a new combination therapy for skin cancer (BCC). Photodynamic Therapy (PDT) is an investigational (experimental) technique that works by combining a photosensitizing topical agent and an intense light source to kill tumor cells. PDT is currently approved for the treatment of BCC in Europe, Canada, and Australia. However, it is experimental in the United States because it is not approved by the Food and Drug Administration (FDA).

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 st…

What they're measuring

BCC: Rate of tumor clearance

Timeframe: Up to 6 months after first treatment visit

Trial details

NCT IDNCT03467789

SponsorCase Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-06

View on ClinicalTrials.gov More Basal Cell Carcinoma trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.