Pilot Trial Comparing Two Different Wavelengths of Light (Blue Versus Red) During Levulan™-Based Photodynamic Therapy of Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Tumor Clearance Rate Following Red or Blue Light PDT
研究概览
简要总结
The investigators will be testing whether aminolevulinate-based (Levulan™) Photodynamic Therapy (PDT) shows effectiveness in the treatment and prevention of cutaneous basal cell carcinoma (BCC) in Basal Cell Nevus Syndrome (BCNS) patients. Levulan™ PDT is an FDA-approved method widely used currently for squamous precancers of the skin. The investigators hypothesize that PDT will provide exceptional benefit in the BCNS population because PDT is nonmutagenic, nonscarring, and can be safely repeated many times. Additionally, the study will investigate whether there are any differences in tumor clearance between the Blu-U® (blue lamp) and Aktilite™(red lamp) therapies.
详细描述
This is a pilot intra-patient comparative study to evaluate the ability of cyclic Photodynamic Therapy (PDT) using Red (635 nm) or Blue (400 nm) light with 5-Aminolevulinic acid, to eliminate BCC skin cancers that occur in patients with Basal Cell Nevus Syndrome (Gorlin-Goltz Syndrome).
Patients will receive 3 cycles of Red light and Blue light PDT treatments, for a total of 6 treatments, over a 4 month period. Cycles will be spaced 2 months apart. Each cycle consists of a double course of PDT treatment with treatments spaced one week apart. Every subject will be treated with two light sources, blue and red, according to randomized assignments made to left side or right side of the body. There will be a final assessment visit at month 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men, women, and children of any age or ethnic group who meet eligibility
- •Patients under 18 years of age must be accompanied and co-consented, by a parent or legal guardian.
- •Patients must have a diagnosis of Basal Cell Nevus Syndrome (BCNS)
- •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 PTCH1 gene mutation
- •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
- •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
- •(6) other rare abnormalities
- •At least two BCC tumors, preferably more, located in different body regions or located greater than 10 cm apart in locations that can be reproducibly separated into red and blue illumination fields
- •Female subjects are not pregnant or nursing or planning to become pregnant during the study
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document
排除标准
- •Pregnant, planning on getting pregnant or nursing
- •Currently participating in another clinical trial
- •Using any topical treatment for their BCC tumors, unless discontinued at least 1 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 a history of a photosensitivity disease, including porphyria cutanea tarda
研究组 & 干预措施
Red Light PDT and Blue Light PDT
The tumor clearance with one side treated with Levulan and Red light PDT, and the contralateral side treated with Blue light PDT.
干预措施: Levulan (Drug)
Red Light PDT and Blue Light PDT
The tumor clearance with one side treated with Levulan and Red light PDT, and the contralateral side treated with Blue light PDT.
干预措施: Red Light PDT (Other)
Red Light PDT and Blue Light PDT
The tumor clearance with one side treated with Levulan and Red light PDT, and the contralateral side treated with Blue light PDT.
干预措施: Blue Light PDT (Other)
结局指标
主要结局
Tumor Clearance Rate Following Red or Blue Light PDT
时间窗: 6 months
The rate of clearance of existing BCC tumors will be assessed in patients with BCNS, using clinical and photographic measurements. The endpoint will be assessed for tumors in a Red light treatment field and a Blue light treatment field in each patient, and compared (bilateral intrapatient comparison).
次要结局
- Patient Satisfaction Survey(6 months)
- Pain During Illumination(Maximum value reported during the illumination period)
研究者
Edward Maytin, MD, PhD
Staff
The Cleveland Clinic