Basal Cell Carcinoma Clinical Trial
Official title:
Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma in Basal Cell Nevus Syndrome
Verified date | May 2024 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 37 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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; - (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 Exclusion Criteria: - 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. - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center | Cleveland | Ohio |
United States | Medical Dermatology Specialists Phoenix | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Up to 6 months after first treatment visit | |
Secondary | 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. | Up to 6 months after first treatment visit | |
Secondary | 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 | Up to 6 months after first treatment visit | |
Secondary | 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 | Up to 6 months after first treatment visit | |
Secondary | 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 | Up to 6 months after first treatment visit | |
Secondary | Erythema score | A measure of Patient Satisfaction Score. Score from photographs on a scale from 1-4 with higher scores indicating more erythema | Up to 6 months after first treatment visit | |
Secondary | 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) | Up to 6 months after first treatment visit | |
Secondary | 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) | Up to 6 months after first treatment visit |
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