A Phase 1 interventional study of Dietary Vitamin D3 pre-treatment and Photodynamic therapy in Basal Cell Carcinoma and Basal Cell Nevus Syndrome, sponsored by Case Comprehensive Cancer Center. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Case Comprehensive Cancer Center · Phase 1, Interventional, and Treatment
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Among 20 studies in Basal Cell Nevus Syndrome with a site in United States — 1 open to participants now, 1 under way, none of them phase 3. Basal Cell Nevus Syndrome · United States.
Among the 20 studies in Basal Cell Nevus Syndrome with a site in United States, this one is the 7th largest by enrollment of the 18 interventional ones that give a count, is the only one that started in 2018, is one of 2 in phase 1, and was the 15th registered.
35 studies on the registry are indexed under Basal Cell Nevus Syndrome; 4 are open to participants now.
Browse Basal Cell Nevus Syndrome studies →1 of the 20 studies in Basal Cell Nevus Syndrome with a site in United States is open now. Recruiting first, the newest first:
St. Jude Children's Research Hospital · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 3 Basal Cell Nevus Syndrome studies recruiting now, 3 set no upper age limit and none stop at 75 or younger; 3 take children under 18; none take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 11 · Phase 3 3
First in 2004; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 37 is above the median of 24 across 25 interventional studies indexed under Basal Cell Nevus Syndrome.
Median enrollment 35 across the 18 interventional studies, 765 across the 2 observational. Of the 18 that completed or were terminated, 12 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 20 have an industry lead sponsor. The 10 most frequent:
Case Comprehensive Cancer Center is the lead sponsor of 494 studies on the registry; 59 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Case Comprehensive Cancer Center has 1 study filed under Basal Cell Nevus Syndrome — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Basal Cell Nevus Syndrome with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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).
The overall hypothesis is that PDT could provide exceptional benefit in patients with Basal Cell Nevus Syndrome (BCNS) and multiple BCC tumors because PDT is nonmutagenic, nonscarring, and can be safely repeated many times. The specific study hypothesis is that Vitamin D might be useful as a neoadjuvant to improve tumor responses to PDT. In preclinical studies, the investigators showed that epithelial tumors are more responsive to aminolevulinic acid (ALA)-based PDT when "primed" by pre-exposure to the dietary form of Vitamin D (cholecalciferol, D3). This study will test the hypothesis that oral D3 supplements, administered over a relatively short time, can boost the effectiveness of PDT for cutaneous (BCC) in this patient population. Patients with BCNS and multiple BCC, or normal patients with at least 3 BCC tumors, will be enrolled. They will receive three PDT treatments, at two-month intervals, over a 6 month period.
Primary Objective
Secondary Objective(s)
Study Design:
In this clinical study, each patient will serve as his or her own control with respect to BCC tumor responsiveness to neoadjuvant D3 supplementation. The first two PDT treatments will be randomized. Thus, patients in Group A will take D3 pills prior to the first PDT treatment, and placebo pills prior to the second PDT treatment. For patients in Group B, the order is reversed. Total amounts of D3 supplementation given will be adjusted, based upon serum 25-hydroxy-D3 levels found at baseline. Patients with VD deficiency will take 14 days of neoadjuvant D3, vs. only 5 days if the initial VD level is normal.
35 studies on the registry are indexed under Basal Cell Nevus Syndrome; 4 are open to participants now.
This study's enrollment of 37 is above the median of 24 across 25 interventional studies indexed under Basal Cell Nevus Syndrome.
Browse Basal Cell Nevus Syndrome studies →Case Comprehensive Cancer Center is the lead sponsor of 494 studies on the registry; 59 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Compared within Basal Cell Nevus Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Carcinoma, Basal Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of Basal Cell Nevus Syndrome (BCNS) as defined in the Consensus Statement from the first International colloquium on BCNS.
Major Criteria are:
Minor Criteria are:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Dietary Vitamin D3 pre-treatment · Radiation: Photodynamic therapy · Drug: Serum Maintenance Vitamin D3
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
Drug: Dietary Vitamin D3 pre-treatment · Radiation: Photodynamic therapy · Drug: Serum Maintenance Vitamin D3
The daily dose of D3 will always be 10,000 IU/day. Total amounts of D3 supplementation given will be adjusted, based upon serum 25-hydroxy-D3 levels found at baseline. Duration of pretreatment will be 14 days if the D3 level is \< 31 ng/mL, and 5 days if the D3 level is \> 31 ng/mL
Photodynamic Therapy (PDT) is an experimental technique that works by combining a photosensitizing topical agent and an intense light source to kill tumor cells.
Also known as: PDT
2,000 IU/d for adults, 1,000 IU/d for children taken after third visit.
BCC: Rate of tumor clearance
Change in tumor diameter per month. For each participant, the investigators will analyze the difference in tumor clearance between treatments, one with neoadjuvant D3+PDT, the other with PDT alone, and the other with or without D3 in order to establish a D3 replete state. The order of the first two treatments is randomized in case the assumption of a linear tumor clearance rate is incorrect The statistical significance of the difference in Delta-T after D3+PDT versus the difference in Delta-T after PDT alone will be tested using ANOVA.
Time frame: Up to 6 months after first treatment visit
BCC: Level of protoporphyrin IX (PpIX) accumulation in BCC lesions
For each patient, whether in the absence or presence of neoadjuvant Vitamin D3, assessments of PpIX accumulation in BCC lesions using fluorescence dosimetry measurements will be made at selected treatment visits.
Time frame: Up to 6 months after first treatment visit
Serum 25-hydroxy-vitamin D3 (25OH-D3) levels
Using a 10mL blood sample, a 25OH-D3 assay will be used to determine D3 levels in the blood
Time frame: Up to 6 months after first treatment visit
Number of patients with active form of leukocyte DNA vitamin D Receptor (VDR)
Study team will collect patients' leukocyte DNA and examine the VDR gene sequences directly. Patients with the active VDR allele are postulated to have better PDT outcomes
Time frame: Up to 6 months after first treatment visit
Pain scale measurement
average pain scale measurements to assess tolerability of the technique to be taken in the week following each PDT treatment (3 total). Ranging from 0 to 10 where 0 indicates no pain and 10 indicates the worst pain possible
Time frame: Up to 6 months after first treatment visit
Erythema score
A measure of Patient Satisfaction Score. Score from photographs on a scale from 1-4 with higher scores indicating more erythema
Time frame: Up to 6 months after first treatment visit
Satisfaction with treatment outcome from the technique
A participant satisfaction questionnaire will be administered at the final study visit measuring the participant's satisfaction with the treatment outcome on a 5 point scale (Extremely Satisfied to Extremely Dissatisfied)
Time frame: Up to 6 months after first treatment visit
Satisfaction with cosmetic outcome from the technique
A participant satisfaction questionnaire will be administered at the final study visit measuring the participant's satisfaction with the cosmetic outcome on a 5 point scale (Extremely Satisfied to Extremely Dissatisfied)
Time frame: Up to 6 months after first treatment visit
Ran from Oct 2018 to primary completion in Jan 2023, 51 months.
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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