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Radiation Therapy

Vitamin D + Photodynamic Therapy for Basal Cell Carcinoma

Phase 1

Waitlist Available

Led By Edward V. Maytin, MD, PhD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Basal Cell Nevus Syndrome (BCNS) as defined in the Consensus Statement from the first International colloquium on BCNS

At least three BCC tumors, two of which are biopsy-proven

Must not have

Currently undergoing treatment for other cancers with medical or radiation therapy

Participants with history of a photosensitivity disease, such as porphyria cutanea tarda

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months after first treatment visit

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the use of PDT in patients with multiple BCCs. The study will also try 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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects of PDT may include skin redness, swelling, pain at the site of treatment, and photosensitivity reactions. Since this trial involves vitamin supplementation, there's also a risk of high calcium levels in blood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Basal Cell Nevus Syndrome.

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I have at least three basal cell carcinomas, with two confirmed by biopsy.

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I will not become pregnant during the study.

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I have had skin cancer or specific symptoms related to BCNS before age 20, or a family history of BCNS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving treatment for another cancer.

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I have a history of a condition that makes my skin sensitive to light.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months after first treatment visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months after first treatment visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after first treatment visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BCC: Rate of tumor clearance

Secondary study objectives

BCC: Level of protoporphyrin IX (PpIX) accumulation in BCC lesions

Erythema score

Number of patients with active form of leukocyte DNA vitamin D Receptor (VDR)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary Vitamin D3 pre-treatment

2018

Completed Phase 1

~40

Photodynamic therapy

2008

Completed Phase 4

~760