Photodynamic Therapy Using Blue Light or Red Light in Treating Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
Conditions
Basal Cell Carcinoma of the Skin - Nevoid Basal Cell Carcinoma Syndrome
Conditions: official terms
Basal Cell Nevus Syndrome - Carcinoma - Carcinoma, Basal Cell - Skin Neoplasms - Syndrome
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: aminolevulinic acid hydrochloride Type: Drug
Name: photodynamic therapy Type: Drug
Name: photodynamic therapy Type: Drug
Name: laboratory biomarker analysis Type: Other
Name: questionnaire administration Type: Other
Overall Status
Not yet recruiting
Summary
This pilot randomized phase II trial studies how well photodynamic therapy using blue light or red light works in treating basal cell cancer (carcinoma) in patients with a genetic condition that causes unusual facial features and disorders of the skin, bones, nervous system, eyes, and endocrine glands, also called basal cell nevus syndrome. Photodynamic therapy uses drugs, such as aminolevulinic acid hydrochloride, that are taken up by tumor cells and when exposed to an intensive light source (blue light or red light) become active and may kill the cells. It is not yet known whether photodynamic therapy is more effective with blue light or red light in treating basal cell carcinoma.
Detailed Description
PRIMARY OBJECTIVES:

I. To determine whether cyclic photodynamic therapy (PDT) treatment is effective in curing existing basal cell carcinoma (BCC) tumors in patients with basal cell nevus syndrome (BCNS), and whether red light or blue light is more effective in this regard.

SECONDARY OBJECTIVES:

I. To assess the tolerability (pain during treatment) of red light versus blue light in this patient population.

II. To assess patient satisfaction with the technique.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive aminolevulinic acid hydrochloride topically. Beginning 4 hours later, patients undergo photodynamic therapy using blue light on the left side of the body and red light on the right side of the body on days 1 and 8. Treatment repeats every 2 months for 3 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive aminolevulinic acid hydrochloride topically. Beginning 4 hours later, patients undergo photodynamic therapy using blue light on the right side of the body and red light on the left side of the body on days 1 and 8. Treatment repeats every 2 months for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

- A diagnosis of basal cell nevus syndrome (BCNS) as defined in the Consensus Statement (Bree et al, American Journal of Medical Genetics [Am J Med Genet] Part A 155:2091-2097)

- Major criteria are:

- 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

- Minor criteria are:

- Rib anomalies, or other specific skeletal malformations including kyphoscoliosis and short 4th metacarpals

- Macrocephaly

- Cleft/lip or palate

- Fibroma of the heart or ovary

- Ocular abnormalities

- Other rare abnormalities listed in the article by Bree et al

- For diagnosis of BCNS, the patient must have either 2 major criteria, one major and two minor criteria, or one major criterion plus molecular confirmation of a patched 1 (PTCH1) gene mutation

- At least two BCC tumors, preferably more; these tumors must be located in different body regions or alternatively, located > 10 cm apart at sites that can be reproducibly separated into red and blue illumination fields

- Female subjects must not become pregnant during the study; 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; for male participants in the study, the use of contraception for themselves or their partners is not required

- Subjects must be able to understand and be willing to sign a written informed consent document

- Patients should have a performance status (Karnofsky score) of > 80 out of 100, i.e. can carry on normal activity with effort while showing some signs or symptoms of disease

- Laboratory requirements:

- If the patient has never had a skin biopsy to establish the histological diagnosis of BCC as part of his/her syndrome, then one lesion must be biopsied prior to entry into the trial

- Any suspected BCC lesion of > 10 mm in diameter must be biopsied at the start of the trial, to establish the histological subtype of the BCC

- Any presumed BCC lesion that fails to respond by the end of the trial must be biopsied to rule out an incorrect diagnosis as a reason for the lack of response

- If a female patient suspects she is pregnant during the course of the trial, a serum pregnancy test will be administered and if positive, any further PDT treatments will be halted

Exclusion Criteria:

- Pregnant or nursing

- Currently participating in another clinical trial

- Using any systemic treatment for BCC (e.g. vismodegib), or any topical treatment for their BCC tumors, unless discontinued at least one month prior

- Currently being treated 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

- Patients with a coexisting skin condition such as scleroderma, psoriasis, or eczema in the skin areas to be treated with PDT, that might interfere with response assessment
Location
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Status: Not yet recruiting
Contact: Edward Maytin - 216-445-6676 - maytine@ccf.org
Start Date
May 2015
Completion Date
December 2016
Sponsors
Case Comprehensive Cancer Center
Source
Case Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page