Status:
COMPLETED
Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Basal Cell Carcinoma
Basal Cell Nevus Syndrome
Eligibility:
All Genders
Phase:
PHASE1
Brief 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...
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 safe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2023
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03467789
Start Date
October 1 2018
End Date
January 6 2023
Last Update
October 17 2024
Active Locations (2)
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1
Medical Dermatology Specialists Phoenix
Phoenix, Arizona, United States, 85006
2
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195