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

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center; The Cleveland Clinic
• Collaborators: Harvard Medical School; University of Arizona
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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.