Basal Cell CarcinomaPhase 1NCT03467789
Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma
A Phase 1 study testing Dietary Vitamin D3 pre-treatment, Photodynamic therapy and Serum Maintenance Vitamin D3 in people with Basal Cell Carcinoma and Basal Cell Nevus Syndrome, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Basal Cell Carcinoma, Basal Cell Nevus Syndrome
- What is being tested?
- Dietary Vitamin D3 pre-treatment, Photodynamic therapy and Serum Maintenance Vitamin D3
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2018to 6 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Basal Cell Nevus Syndrome (BCNS) as defined in the Consensus Statement from the first International colloquium on BCNS.
- Major Criteria are:
- (1) BCC prior to age 20 years, or excessive number of BCCs out of proportion to prior sun exposure and skin type;
- (2) keratocyst of the jaw prior to age 20;
- (3) palmar or plantar pitting;
- (4) lamellar calcification of the falx cerebri;
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- (5) medulloblastoma;
- (6) first degree relative with BCNS;
- (7) Patched-1 (PTCH1) gene mutation.
- Minor Criteria are:
- (1) rib anomalies, or other specific skeletal malformations including kyphoscoliosis and short 4th metacarpals;
- (2) macrocephaly;
- (3) cleft/lip or palate;
- (4) fibroma of the heart or ovary;
- (5) ocular abnormalities;
- For diagnosis of BCNS, the participant must have either 2 major criteria, one major and two minor criteria.
- At least three BCC tumors, two of which are biopsy-proven
- Female subjects must not become pregnant during the study
- Subjects must be able to understand and willing to sign a written informed consent document
Who cannot join
- Pregnant or nursing.
- At risk for hypercalcemia (renal disease, sarcoidosis, etc.)
- Taking vismodegib or a hedgehog pathway inhibitor; must stop at least 3 months prior to visit 1.
- Taking any topical treatment on their BCC tumors; must stop at least 1 month prior.
- Taking Vitamin D or multivitamin supplements; must stop at least 1 month prior.
- Currently undergoing treatment for other cancers with medical or radiation therapy.
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- Participants with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material.
- Participants with history of a photosensitivity disease, such as porphyria cutanea tarda.
- Currently participating in another clinical trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Medical Dermatology Specialists Phoenix
Phoenix, Arizona, 85006
About this study
Official title: Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma in Basal Cell Nevus Syndrome
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).
Read the detailed description
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
- To determine tumor clinical clearance rates after neoadjuvant D3/PDT, and after PDT alone. To accomplish this, the first two PDT treatments in each study patient will be randomized, i.e. one PDT session will be performed after D3 pretreatment, the other without any pretreatment.
Secondary Objective(s)
- To assess the level of PpIX accumulation in BCC lesions at various treatment visits, in the absence or presence of neoadjuvant D3. (Fluorescence dosimetry measurements)
- To assess tolerability of the technique. (Pain scale measurements)
- To assess patient satisfaction with the technique. (Cosmetic result, and questionnaire)
- To assess D3 serum levels (in serum) and VDR status (in leukocyte DNA), and correlate these results to clinical outcomes.
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.
- Conditions
- Basal Cell Carcinoma, Basal Cell Nevus Syndrome
- Being tested
- Dietary Vitamin D3 pre-treatment, Photodynamic therapy, Serum Maintenance Vitamin D3
- Keywords
- Vitamin D, Photodynamic Therapy
- Medical subject headings
- Carcinoma, Basal Cell, Basal Cell Nevus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Vitamin D3 pre-treatmentDrug
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 therapyRadiation
Also called PDT
Photodynamic Therapy (PDT) is an experimental technique that works by combining a photosensitizing topical agent and an intense light source to kill tumor cells.
Serum Maintenance Vitamin D3Drug
2,000 IU/d for adults, 1,000 IU/d for children taken after third visit.
| Study group | Role | What they receive |
|---|---|---|
| Group A: D3 prior to first PDT | Experimental | 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 Receives: Drug: Dietary Vitamin D3 pre-treatment; Radiation: Photodynamic therapy; Drug: Serum Maintenance Vitamin D3 |
| Group B: D3 prior to second PDT visit | Experimental | 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 Receives: Drug: Dietary Vitamin D3 pre-treatment; Radiation: Photodynamic therapy; Drug: Serum Maintenance Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months after first treatment visit
Secondary outcomes (7)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Up to 6 months after first treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Oct 2018
- Primary completion6 Jan 2023
- Study completion6 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each patient serves as his/her own control. Two PDT sessions are given, constituting Arm 1 and Arm 2. Arm 1 is placebo pill, then PDT. Arm 2 is Vit D pill, then PDT. In any given patient, the order of Arm 1 vs. Arm 2 will be randomized.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward V. Maytin, MD, PhD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467789
- Sponsor's protocol ID
- CASE5617
- Status last verified
- Oct 2024
- First submitted
- 12 Mar 2018
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma in Basal Cell Nevus Syndrome
- ClinicalTrials.gov ID
- NCT03467789
- Acronym / sponsor ID
- CASE5617
- Conditions
- Basal Cell Carcinoma, Basal Cell Nevus Syndrome
- Keywords
- Vitamin D, Photodynamic Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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
- To determine tumor clinical clearance rates after neoadjuvant D3/PDT, and after PDT alone. To accomplish this, the first two PDT treatments in each study patient will be randomized, i.e. one PDT session will be performed after D3 pretreatment, the other without any pretreatment.
Secondary Objective(s)
- To assess the level of PpIX accumulation in BCC lesions at various treatment visits, in the absence or presence of neoadjuvant D3. (Fluorescence dosimetry measurements)
- To assess tolerability of the technique. (Pain scale measurements)
- To assess patient satisfaction with the technique. (Cosmetic result, and questionnaire)
- To assess D3 serum levels (in serum) and VDR status (in leukocyte DNA), and correlate these results to clinical outcomes.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Each patient serves as his/her own control. Two PDT sessions are given, constituting Arm 1 and Arm 2. Arm 1 is placebo pill, then PDT. Arm 2 is Vit D pill, then PDT. In any given patient, the order of Arm 1 vs. Arm 2 will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Group A: D3 prior to first PDT | Experimental | Drug: Dietary Vitamin D3 pre-treatment, Radiation: Photodynamic therapy, Drug: Serum Maintenance Vitamin D3In 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 |
| Group B: D3 prior to second PDT visit | Experimental | Drug: Dietary Vitamin D3 pre-treatment, Radiation: Photodynamic therapy, Drug: Serum Maintenance Vitamin D3In 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- 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
- Female subjects must not become pregnant during the study
- Subjects must be able to understand and willing to sign a written informed consent document
Key exclusion criteria (9 listed)
- Pregnant or nursing.
- At risk for hypercalcemia (renal disease, sarcoidosis, etc.)
- Taking vismodegib or a hedgehog pathway inhibitor; must stop at least 3 months prior to visit 1.
- Taking any topical treatment on their BCC tumors; must stop at least 1 month prior.
- Taking Vitamin D or multivitamin supplements; must stop at least 1 month prior.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Vitamin D3 pre-treatmentThe 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 | Drug | Group A: D3 prior to first PDT, Group B: D3 prior to second PDT visit |
| Photodynamic therapyAlso: PDTPhotodynamic Therapy (PDT) is an experimental technique that works by combining a photosensitizing topical agent and an intense light source to kill tumor cells. | Radiation | Group A: D3 prior to first PDT, Group B: D3 prior to second PDT visit |
| Serum Maintenance Vitamin D32,000 IU/d for adults, 1,000 IU/d for children taken after third visit. | Drug | Group A: D3 prior to first PDT, Group B: D3 prior to second PDT visit |
Primary outcome
BCC: Rate of tumor clearance
Time frame: Up to 6 months after first treatment visit
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.
7 secondary outcomes
BCC: Level of protoporphyrin IX (PpIX) accumulation in BCC lesions
Time frame: Up to 6 months after first treatment visit
Serum 25-hydroxy-vitamin D3 (25OH-D3) levels
Time frame: Up to 6 months after first treatment visit
Number of patients with active form of leukocyte DNA vitamin D Receptor (VDR)
Time frame: Up to 6 months after first treatment visit
Pain scale measurement
Time frame: Up to 6 months after first treatment visit
Erythema score
Time frame: Up to 6 months after first treatment visit
Satisfaction with treatment outcome from the technique
Time frame: Up to 6 months after first treatment visit
Satisfaction with cosmetic outcome from the technique
Time frame: Up to 6 months after first treatment visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward V. Maytin, MD, PhD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dietary Vitamin D3 pre-treatment, Photodynamic therapy and Serum Maintenance Vitamin D3 in people with Basal Cell Carcinoma and Basal Cell Nevus Syndrome, run by Case Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCC: Rate of tumor clearance (time frame: Up to 6 months after first treatment visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.