A Pilot Study of Photodynamic Therapy in Refractory Plaques and Tumors of Mycosis Fungoides
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Complete clinical response
研究概览
简要总结
This pilot phase II trial studies how well photodynamic therapy works in treating patients with mycosis fungoides that does not respond to treatment. Photodynamic therapy uses a drug, such as aminolevulinic acid hydrochloride, that becomes active when it is exposed to light. The activated drug may kill cancer cells.
详细描述
PRIMARY OBJECTIVES:
I. To determine the efficacy of photodynamic therapy (PDT) in refractory tumors and plaques of mycosis fungoides (MF).
SECONDARY OBJECTIVES:
I. To determine the effects of sequential PDT and radiation therapy (RT). II. To determine the side effect profile of PDT in MF.
EXPLORATORY OBJECTIVES:
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
- 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
- •Histological confirmation of mycosis fungoides as confirmed by the Mayo Clinic Arizona Dermatopathology Department
- •Patients must have a tumor or plaque that is refractory to conventional treatment including but not limited to one of the following (up to 4 lesions in a single field of PDT or RT will be considered for treatment):
- •Plaque stage disease that has failed at least 2 skin directed therapies (including topical steroids) or refractory plaques despite at least one systemic therapy or plaques with evidence of folliculotropism
- •The presence of a tumor of MF
- •Negative urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Provide written informed consent
- •Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
排除标准
- •Prior radiation to the same site deemed to be too high of level of radiation for retreatment
- •Photosensitivity disorder, including but not limited to porphyria, or concomitant photosensitizing drugs that place the patient at an elevated risk of developing severe side effects to PDT or RT
- •Skin cancer other than actinic keratosis, basal cell carcinoma, and squamous cell carcinoma in situ in the field of RT
- •Active infection at the site to be irradiated
- •Any underlying condition which prevents the patient from being able to undergo the required number of sessions of PDT or RT and required follow up
- •Pregnancy
- •Lactation and a radiation field which would include the breast or nipple or deemed to place the mother or child at elevated risk of radiation exposure (evaluated by MRP, ARM, WR, WW)
- •An allergy to a component of Levulan
- •Women of childbearing potential (post-menopausal or not of child-bearing potential) is defined by: 1 year of natural (spontaneous) amenorrhea or surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago; oophorectomy alone must confirmed by follow up hormone level assessment to be considered not of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception which includes:
- •Total abstinence (Periodic abstinence and withdrawal are not acceptable methods of contraception)
- •Female sterilization (bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment; oophorectomy alone requires follow up hormone level assessment for fertility
- •Male sterilization (at least 6 months prior to screening); the vasectomized male partner should be the sole partner for that subject
- •Barrier methods of contraception: condom or occlusive cap
- •Use of oral, injected or implanted hormonal methods of contraception or other forms or hormonal contraception that have complete efficacy (failure < 1%); (the dose of the contraceptive should be stable for 3 months)
- •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
- •Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
Treatment (aminolevulinic acid hydrochloride, PDT, RT)
Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation therapy daily for 4 weeks.
干预措施: Aminolevulinic Acid Hydrochloride (Drug)
Treatment (aminolevulinic acid hydrochloride, PDT, RT)
Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation therapy daily for 4 weeks.
干预措施: Photodynamic Therapy (Drug)
Treatment (aminolevulinic acid hydrochloride, PDT, RT)
Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation therapy daily for 4 weeks.
干预措施: Quality-of-Life Assessment (Other)
Treatment (aminolevulinic acid hydrochloride, PDT, RT)
Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation therapy daily for 4 weeks.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Complete clinical response
时间窗: At 24 weeks
Will be determined by Composite Assessment of Index Lesion Severity (CAILS) and Physician Global Assessment (PGA).
次要结局
- Change in field of treatment(Baseline up to week 24)
- Incidence of adverse events (AEs)(Up to 2 years)
- Change in CAILS score(Baseline up to week 24)
- Change in Skindex-16 score(Baseline up to week 24)