Vitamin D + Photodynamic Therapy for Basal Cell Carcinoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byEdward V. Maytin, MD, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Case Comprehensive Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Edward V. Maytin, MD, PhD

Principal Investigator

Cleveland Clinic, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals with multiple Basal Cell Carcinoma (BCC) tumors, specifically those diagnosed with Basal Cell Nevus Syndrome (BCNS). Participants must meet certain criteria including having BCC before age 20 or a PTCH1 gene mutation. Women in the study cannot be pregnant and all participants should not take Vitamin D supplements or other cancer treatments one month prior.

Inclusion Criteria

Subjects must be able to understand and willing to sign a written informed consent document

I have been diagnosed with Basal Cell Nevus Syndrome.

I have specific bone, head, mouth, heart, ovary, or eye conditions.

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Exclusion Criteria

I am at risk for high calcium levels due to conditions like kidney disease.

I stopped taking vismodegib or any hedgehog inhibitor 3 months ago.

I have stopped any skin-applied treatments for my cancer at least a month ago.

See 6 more

Treatment Details

Interventions

Dietary Vitamin D3 pre-treatment (Vitamin Supplement)
Photodynamic therapy (Radiation Therapy)
Serum Maintenance Vitamin D3 (Vitamin Supplement)

Trial OverviewThe trial is testing if taking dietary Vitamin D3 before Photodynamic Therapy (PDT) improves treatment outcomes for BCC. PDT combines a light-sensitive cream and light exposure to destroy cancer cells but isn't FDA-approved in the U.S. yet. The study aims to establish oral Vitamin D3/PDT as a new skin cancer therapy.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Group B: D3 prior to second PDT visitExperimental Treatment3 Interventions

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

Group II: Group A: D3 prior to first PDTExperimental Treatment3 Interventions

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