Vitamin D Given before Photodynamic Therapy When Treating Patients with Basal Cell Cancer in Basal Cell Nevus Syndrome

Status: Active

Description

This phase I trial studies how well vitamin D works when given before photodynamic therapy when treating patients with basal cell cancer in basal cell nevus syndrome. Giving vitamin D before photodynamic therapy may help improve the effectiveness of treatment. Photodynamic therapy is a noninvasive treatment in which a topical agent called Levulan or ALA is applied to the skin and then exposed to blue light, which targets and kills tumor cells. It is not yet known how well vitamin D works when given before photodynamic therapy in patients with basal cell cancer in basal cell nevus syndrome.

Eligibility Criteria

Inclusion Criteria

  • A diagnosis of basal cell nevus syndrome (BCNS) as defined in the consensus statement from the first International Colloquium on BCNS.
  • MAJOR CRITERIA:
  • BCC prior to age 20 years, or excessive number of BCCs out of proportion to prior sun exposure and skin type.
  • Keratocyst of the jaw prior to age 20.
  • Palmar or plantar pitting.
  • Lamellar calcification of the falx cerebri.
  • Medulloblastoma.
  • First degree relative with BCNS.
  • PTCH1 gene mutation.
  • MINOR CRITERIA:
  • Rib anomalies, or other specific skeletal malformations including kyphoscolosis and short 4th metacarpals.
  • Macrocephaly.
  • Cleft/lip or palate.
  • Fibroma of the heart or ovary.
  • Ocular abnormalities.
  • Other rare abnormalities listed in the article.
  • For diagnosis of BCNS, the patient must have either 2 major criteria, one major and two minor criteria.
  • At least three BCC tumors, two of which are biopsy-proven. Since BCNS patients tend to have a similar clinical pattern for all their tumors, biopsy of 2 lesions will provide a reasonable sampling to assure a proper diagnosis. To enhance our ability to reach the enrollment target, non-BCNS patients with multiple BCC tumors (patients without a diagnosis of BCNS, but with at least 3 BCC tumors present simultaneously) will also be eligible for this study. Histological confirmation of BCC in two of the clinically-diagnosed BCC lesions will be obtained, either at the enrollment/screening visit by performing skin biopsies that same day, or by obtaining the biopsy report if those lesions were biopsied elsewhere.
  • Female subjects must not become pregnant during the study. The effects of 5-aminolevulinic acid (Levulan) on the developing human fetus are unknown. Female subjects must not become pregnant during the study. The effects of 5-aminolevulinic acid (Levulan) on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (double barrier method of birth control or abstinence) prior to study entry, and for the duration of study participation. Should a woman become pregnant or suspect that she is pregnant while she is participating in this study, she should inform the treating physician immediately.
  • 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 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.

Locations & Contacts

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Active
Contact: Edward Maytin
Phone: 216-445-6676
Email: maytine@ccf.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine tumor clinical clearance rates after neoadjuvant cholecalciferol (D3)/photodynamic therapy (PDT), and after PDT alone.

SECONDARY OBJECTIVES:

I. To assess the level of protoporphyrin IX (PpIX) accumulation in basal cell carcinoma (BCC) lesions at various treatment visits, in the absence or presence of neoadjuvant D3. (Fluorescence dosimetry measurements)

II. To assess tolerability of the technique. (Pain scale measurements)

III. To assess patient satisfaction with the technique. (Cosmetic result, and questionnaire)

IV. To assess D3 serum levels (in serum) and vitamin D receptor (VDR) status (in leukocyte deoxyribonucleic acid [DNA]), and correlate these results to clinical outcomes.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP A: Patients receive cholecalciferol orally (PO) daily on days 1-5 or 1-14 (depending on serum vitamin D3 levels) and undergo photodynamic therapy with topical aminolevulinic acid hydrochloride (Levulan) on day 0. Patients then receive placebo PO daily on days 1-5 or 1-14 (depending on serum vitamin D3 levels) and undergo a second photodynamic therapy session on at month 2. Patients undergo a third photodynamic therapy session at month 4.

GROUP B: Patients receive placebo PO daily on days 1-5 or 1-14 (depending on serum vitamin D3 levels) and undergo photodynamic therapy with topical Levulan on day 0. Patients then receive cholecalciferol PO daily on days 1-5 or 1-14 (depending on serum vitamin D3 levels) and undergo a second photodynamic therapy session at month 2. Patients undergo a third photodynamic therapy session at month 4.

After completion of each study treatment, patients are followed up in 24-48 hours and followed for up to 6 months.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Case Comprehensive Cancer Center

Principal Investigator
Edward Maytin

Trial IDs

Primary ID CASE5617
Secondary IDs NCI-2018-02325
Clinicaltrials.gov ID NCT03467789