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Radiation Therapy

Vitamin D + Photodynamic Therapy for Basal Cell Carcinoma

Phase 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months after first treatment visit

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

BCC: Rate of tumor clearance

Secondary outcome measures

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,873 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still being considered for enrollment into this trial?

"Clinicialtrials.gov reports that this trial is recruiting patients, with the first post date being October 1st 2018 and last edited on October 20th 2022."

Answered by AI

How many participants are enrolled in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this study is seeking applicants, which it began doing on October 1st 2018 and updated as recently as the 20th of October 2022. 50 participants are wanted between two sites for further investigation."

Answered by AI

What purpose does Dietary Vitamin D3 pre-treatment usually fulfill?

"Dietary Vitamin D3 supplementation is employed as a therapy for calcium deficiency, in addition to spinal fractures and post menopausal women."

Answered by AI

Is the use of Vitamin D3 as a pre-treatment measure sanctioned by the FDA?

"Our analysts at Power assign dietary Vitamin D3 pre-treatment a safety rating of 1, as the data supporting its efficacy and protection is limited due to this being a Phase 1 trial."

Answered by AI

Has there been prior research examining the efficacy of Dietary Vitamin D3 as a pre-treatment?

"Currently, 33 studies are actively investigating the potential of Dietary Vitamin D3 pre-treatment as a medical intervention. Of these trials, 14 have entered Phase 3 and can be found in 155 locations across the United States with multiple sites based in Boston, Massachusetts."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03467789.

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