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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

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 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

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
Photodynamic therapy
2010
Completed Phase 4
~670

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
462 Previous Clinical Trials
32,526 Total Patients Enrolled
Edward V. Maytin, MD, PhDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center
2 Previous Clinical Trials
21 Total Patients Enrolled
1 Trials studying Basal Cell Nevus Syndrome
3 Patients Enrolled for Basal Cell Nevus Syndrome

Media Library

Photodynamic therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03467789 — Phase 1
Basal Cell Nevus Syndrome Research Study Groups: Group A: D3 prior to first PDT, Group B: D3 prior to second PDT visit
Basal Cell Nevus Syndrome Clinical Trial 2023: Photodynamic therapy Highlights & Side Effects. Trial Name: NCT03467789 — Phase 1
Photodynamic therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03467789 — Phase 1
~5 spots leftby Sep 2025
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