Silicon Phthalocyanine Pc4 for Photodynamic Therapy of Cutaneous T-cell Lymphoma: Single and Repeated Photoexposures
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- MTD of Photodynamic Therapy
研究概览
简要总结
This phase I trial studies the side effects and best dose of silicon phthalocyanine 4 and photodynamic therapy in treating patients with stage IA-IIA cutaneous T-cell non-Hodgkin lymphoma. Photodynamic therapy (PDT) uses a drug, silicon phthalocyanine 4, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against cutaneous T-cell non-Hodgkin lymphoma.
Funding Source - FDA OOPD
详细描述
PRIMARY OBJECTIVES:
I. Determine the safety and maximum tolerated dose (MTD) that can be utilized for a single treatment of Pc 4-PDT (silicon phthalocyanine 4 photo dynamic therapy) on subjects with mycosis fungoides (MF)/cutaneous T-cell lymphoma (CTCL) stage IA-IIA, by evaluating an accelerated dose escalation protocol consisting of a single exposure to PDT using topically-applied Pc 4 and visible light at a wavelength of 675 nm, followed by assessment of skin biopsies to analyze cellular and molecular changes induced by Pc 4-PDT. (Cohort I)
II. Determine safety and tolerability of repeated light (PDT) exposures after a single application of Pc 4 to a MF/CTCL plaque, using topically-applied Pc 4 and visible light at a wavelength of 675nm, followed by assessment of skin biopsies to analyze cellular and molecular changes induced by Pc 4-PDT. (Cohort II)
III. Identification of targets for assessment of efficacy to assist in planning for a Phase II study.
OUTLINE: This is a dose-escalation study.
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
- •Diagnosed with early stage MF (CTCL stage IA-IIA)
- •Has at least 2 evaluable plaques
- •Has been off systemic therapies for at least 4 weeks
- •Has been off topical therapies for at least 2 weeks
- •Has been off phototherapies for at least 2 weeks
- •All skin photo-types will be included
- •Subjects must have the ability to understand and the willingness to sign a written informed consent form
- •Women of child-bearing potential must agree to utilize a birth control which results in a failure rate of less that 1% per year during the study; accepted forms of birth control for this study include: injections such as Depo-Provera and Lunelle, implants such as Norplant, and intra-uterine devices
- •Sexually active males must agree to use a medically acceptable form of birth control for the duration of the study and for at least 3 months after the last dose of the study medication; appropriate birth control methods are using a condom with a spermicide or surgical sterilization
排除标准
- •Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria)
- •Any medical condition that could be aggravated or may cause extreme discomfort during the study period
- •Lesions only on the face, scalp or other sites that would make biopsies not cosmetically acceptable
- •Women of childbearing potential who are pregnant or attempting to become pregnant are excluded from this study
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to silicon phthalocyanine (Pc 4) or other agents used in this study
- •Patients with uncontrolled intercurrent 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 (silicon phthalocyanine 4 and PDT)
Patients receive silicon phthalocyanine 4 topically and then undergo PDT.
干预措施: silicon phthalocyanine 4 (Drug)
Treatment (silicon phthalocyanine 4 and PDT)
Patients receive silicon phthalocyanine 4 topically and then undergo PDT.
干预措施: photodynamic therapy (Drug)
Treatment (silicon phthalocyanine 4 and PDT)
Patients receive silicon phthalocyanine 4 topically and then undergo PDT.
干预措施: pharmacological study (Other)
Treatment (silicon phthalocyanine 4 and PDT)
Patients receive silicon phthalocyanine 4 topically and then undergo PDT.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
MTD of Photodynamic Therapy
时间窗: Up to 30 days
Defined as the dose immediately below the dose in which 2 or more of 6 patients experience a grade 4 toxicity assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
MTD of Silicon Phthalocyanine 4 Defined as the Dose Immediately Below the Dose in Which 2 or More of 6 Patients Experience a Grade 4 Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
时间窗: Up to 30 days
次要结局
未报告次要终点
研究者
Kevin Cooper MD
Department Chairman, Dermatology
Case Comprehensive Cancer Center