A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Irradiance-dependent pain threshold
研究概览
简要总结
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. Photodynamic therapy using methyl-5-aminolevulinate hydrochloride cream may be effective against skin cancer. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy with methyl-5-aminolevulinate hydrochloride cream in determining pain threshold patients with skin cancer
详细描述
PRIMARY OBJECTIVES: I. To determine the "low" initial irradiance that causes no or minimal (pain grade of < 4) during the time period during which 90 +/- 10% photo bleaching of protoporphyrin IX (PplX) in the lesion occurs, and which precedes the "high" irradiance portion of MAL/PDT. II. To determine the effects of preceding "low" irradiance on the pain level of the "high" irradiance portion of MAL-PDT. SECONDARY OBJECTIVES: I. To determine the effects of irradiance on lesion perfusion. II. To determine PpIX and Total Vit D content in blood. TERTIARY OBJECTIVES: I. To monitor the clinical outcomes of the treatments for initial response and recurrences. OUTLINE: Patients are randomized to 1 of 2 treatment arms. GROUP I: Patients apply methyl-5-aminolevulinate hydrochloride (MAL) cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo laser light treatment for 3-5 minutes. GROUP II: Patients apply MAL cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo light-emitting diode treatment for 10-20 minutes. After completion of study treatment, patients are followed up at 5-7 days, at 6-12 months, and at 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with 1-2 superficial basal cell carcinoma (sBCC), 0.5 to 2 cm in diameter
- •Primary or recurrent lesions may be treated
- •Diagnosis must be confirmed by biopsy, at least 2 weeks pre treatment
- •Each patient with < 8 lesions can contribute a maximum of 2 lesions per treatment session, 1 lesion per light source, which can be treated the same day as permitted by scheduling; the remaining lesions may be treated as soon as scheduling permits with non protocol Photodynamic Therapy
- •Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Patients not meeting the above selection criteria
- •Lesions which are not suitable for diagnostic measurements
- •Patients with >= 8 lesions to be treated
- •Carcinomas of types known to have uncertain clinical margins (e.g. morpheaform or infiltrating), or any lesion felt to require Mohs surgery for definitive control
- •Lesions over boney prominences
- •Patients with porphyrias or known hypersensitivity to porphyrins
- •Patients with known photosensitivity diseases
- •Patients with allergies to Metvixia (MAL) cream ingredients (peanut and almond oil)
- •Patients previously treated with a systemic photo sensitizer within 4 months
- •Pregnant or nursing female patients
- •Patients unwilling or unable to follow protocol requirements
- •Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
研究组 & 干预措施
Group I
Patients apply methyl-5-aminolevulinate hydrochloride (MAL) cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo laser light treatment for 3-5 minutes.
干预措施: methyl-5-aminolevulinate hydrochloride cream (Drug)
Group I
Patients apply methyl-5-aminolevulinate hydrochloride (MAL) cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo laser light treatment for 3-5 minutes.
干预措施: laser therapy (Procedure)
Group II
Patients apply MAL cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo light emitting diode treatment for 5-10 minutes.
干预措施: methyl-5-aminolevulinate hydrochloride cream (Drug)
Group II
Patients apply MAL cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo light emitting diode treatment for 5-10 minutes.
干预措施: photodynamic therapy (Drug)
结局指标
主要结局
Irradiance-dependent pain threshold
时间窗: 30-60 sec after the initial "low" irradiance treatment, every 3-5 min until irradiance increase, 30-60 sec after the "high" irradiance increase, and every 3-5 min until end of treatment
次要结局
- Efficacy of treatment in terms of clinical response(At 5-7 days, at 6-12 months, and at 24 months)