Vitamin D and Photodynamic Therapy for Treatment of BCC in BCNS
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/12/2018 |
| Start Date: | October 1, 2018 |
| End Date: | May 1, 2023 |
| Contact: | Jeff Negrey, MA |
| Email: | negreyj2@ccf.org |
| Phone: | 216-636-5504 |
Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma in Basal Cell Nevus Syndrome
The purpose of this research is to evaluate the use of Photodynamic Therapy (PDT) to treat
the multiple basal cell carcinoma (BCC) skin cancers in children and adults with Basal Cell
Nevus Syndrome (or who have at least 3 BCC tumors present). In addition, the investigators
will test a hypothesis (based upon our extensive preclinical studies in mice) that induction
of a transient spike in serum Vitamin D levels through administration of dietary Vitamin D
(cholecalciferol; D3) can significantly increase PDT efficacy and improve the clearance of
cutaneous BCC tumors.
the multiple basal cell carcinoma (BCC) skin cancers in children and adults with Basal Cell
Nevus Syndrome (or who have at least 3 BCC tumors present). In addition, the investigators
will test a hypothesis (based upon our extensive preclinical studies in mice) that induction
of a transient spike in serum Vitamin D levels through administration of dietary Vitamin D
(cholecalciferol; D3) can significantly increase PDT efficacy and improve the clearance of
cutaneous BCC tumors.
Patients with a rare genetic syndrome, called Basal Cell Nevus Syndrome or Gorlin-Goltz
Syndrome (caused by a mutation in the PTCH1 gene) will be recruited to participate in this
study. Potential patients will be referred by their local physicians or by the BCCNS Life
Support Network to contact a study coordinator about enrollment.
The study will examine a combination regimen of Vitamin D3/PDT and compare its efficacy in
treating BCC tumors to PDT alone. The hypothesis is that oral D3 supplements, administered
over a relatively short time, can boost the effectiveness of PDT for cutaneous (BCC) in this
patient population. Participants will receive three PDT treatments, at two-month intervals,
over a 6 month period.
Tumor clinical clearance rates after neoadjuvant Vitamin D3/PDT, versus PDT alone, will be
compared within the same patient. Measurement endpoints will include tumor dimensions by
clinical examination, tumor measurements in photographs, PpIX fluorescence, serum 25OH-D3
levels, and characterization of VDR gene alleles. In addition, assessments of the
tolerability (pain scale measurements) and patient satisfaction with the technique will be
measured.
Syndrome (caused by a mutation in the PTCH1 gene) will be recruited to participate in this
study. Potential patients will be referred by their local physicians or by the BCCNS Life
Support Network to contact a study coordinator about enrollment.
The study will examine a combination regimen of Vitamin D3/PDT and compare its efficacy in
treating BCC tumors to PDT alone. The hypothesis is that oral D3 supplements, administered
over a relatively short time, can boost the effectiveness of PDT for cutaneous (BCC) in this
patient population. Participants will receive three PDT treatments, at two-month intervals,
over a 6 month period.
Tumor clinical clearance rates after neoadjuvant Vitamin D3/PDT, versus PDT alone, will be
compared within the same patient. Measurement endpoints will include tumor dimensions by
clinical examination, tumor measurements in photographs, PpIX fluorescence, serum 25OH-D3
levels, and characterization of VDR gene alleles. In addition, assessments of the
tolerability (pain scale measurements) and patient satisfaction with the technique will be
measured.
Inclusion Criteria:
- A diagnosis of Basal Cell Nevus Syndrome (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
Exclusion Criteria:
- Pregnant or nursing
- At risk for hypercalcemia (renal disease, sarcoidosis, etc.)
- Taking vismodegib or a hedgehog pathway inhibitor; must stop at least 1 month prior
- Taking any topical treatment on their BCC tumors; must stop at least one month prior
- Taking Vitamin D or multivitamin supplements; must stop at least one month prior
- Currently undergoing treatment for other cancers with medical or radiation therapy
- Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of
the study material
- Patients with history of a photosensitivity disease, such as porphyria cutanea tarda
- Currently participating in another clinical trial
We found this trial at
2
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Edward Maytin, MD
Phone: 216-636-5504
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