Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Treatment Responses of Index Lesions
研究概览
简要总结
The goal of this clinical trial is to assess the benefit of continuous treatment with synthetic hypericin ointment (HyBryte) and visible light in patients with mycosis fungoides for up to 12 months (54 weeks). Funding Source: FDA OOPD.
详细描述
This is an open label trial in which patients will have their mycosis fungoides (MF) lesions treated twice a week with HyBryte ointment that is followed, 24 hours later (±6 hours), by activation of the drug with visible light treatment. Patients will treat all of their MF lesions (where accessible to light therapy), but 3 to 5 lesions will be identified and followed as "Index Lesions" that will be evaluated using the Composite Assessment of Index Lesion Severity (CAILS) score every 6 weeks for the up to 54 weeks of therapy. Patients will be treated until resolution, dropout for adverse events, or plateau of therapeutic response occurs. Changes in the skin scoring mechanisms such as the CAILs and mSWAT will be tabulated for each patient and assessed across all patients enrolled in the trial to determine the response profile of HyBryte and visible light treatment.
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
- •Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage 1A, Stage 1B, or Stage 2A.
- •(Stage 1 is divided into stages 1A and 1B as follows: Stage 1A: Patches, papules, and/or plaques cover less than 10% of the skin surface. Stage 1B: Patches, papules, and/or plaques cover 10% or more of the skin surface. Stage 2A: Patches, papules, and/or plaques cover any amount of skin surface. Lymph nodes are abnormal, but they are not cancerous.)
- •Subjects willing to follow the clinical protocol and voluntarily give their written informed consent
- •Female subjects not pregnant nor nursing and willing to undergo a pregnancy test within 21 days prior to treatment initiation and agree to use a medically accepted method of birth control such as oral contraceptives (birth control pill), Barrier method (condom plus spermicide or diaphragm plus spermicide) or abstaining from intercourse while on study
排除标准
- •History of allergy or hypersensitivity to any of the components of SGX301
- •Pregnancy or mothers who are breast-feeding
- •Males and females not willing to use effective contraception
- •Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g., porphyria, systemic lupus erythematosus, Sjogren's, etc.).
- •Subjects whose condition is spontaneously improving.
- •Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on lesions for CTCL within 2 weeks of enrollment
- •Subjects receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment
- •Subjects who have received electron beam irradiation within 3 months of enrollment
- •Subjects with a history of significant systemic immunosuppression
- •Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment
- •Subject with any condition that, in the judgment of the PI, is likely to interfere with participation in the study
- •Subjects receiving drugs known to cause photosensitization within 2 weeks of starting SGX301 therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks.
研究组 & 干预措施
HyBryte (0.25 % Hypericin) with Visible Light
HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 24 (±6) hours later starting at 5 J/cm^2. Drug application/light sessions will be done twice a week (at least 2 calendar days apart) for up to 54 weeks.
干预措施: Hypericin (Drug)
HyBryte (0.25 % Hypericin) with Visible Light
HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 24 (±6) hours later starting at 5 J/cm^2. Drug application/light sessions will be done twice a week (at least 2 calendar days apart) for up to 54 weeks.
干预措施: Visible Light (Other)
结局指标
主要结局
Number of Treatment Responses of Index Lesions
时间窗: Baseline up to 54 weeks
A Treatment Response is defined as a ≥50% improvement in the Composite Assessment of Index Lesion Severity (CAILS) score score at each evaluation timepoint (every 6 weeks up to 54 weeks) when compared to the CAILS score at baseline. The CAILS score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\^2) to 18 (the lesion is larger than 300 cm\^2). A lower score means a better outcome. The overall CAILS score is calculated by adding the total score as described above for each of the 3-5 index lesions. A lower score means a better outcome.
次要结局
- The time needed to achieve at least a 50% change in the cumulative CAILS score of Index Lesions from baseline.(Baseline up to 54 weeks.)
- The relative change in CAILS score for lesions classified as patch compared to plaque from baseline to end of treatment.(Baseline up to 54 weeks)
- The time to maximal response in cumulative CAILS score.(Baseline up to 54 weeks)
- The time to maximal response in cumulative PGA score.(Baseline up to 54 weeks)
- The percent of patients achieving a Complete Response of All Lesions(Baseline up to 54 weeks)
- The percent of patients achieving a PGA score of 3 (moderate improvement) from baseline to end of treatment.(Baseline up to 54 weeks)
- The percent of patients achieving at least 50% change in VASitch from baseline to end of treatment.(Baseline up to 54 weeks)
- The percent of patients achieving at least 50% change in the mSWAT (overall skin score) from baseline to end of treatment.(Baseline up to 54 weeks)
- The change in CAILS score for each Index Lesion from baseline to end of treatment.(Baseline up to 54 weeks.)
- The time to maximal response in cumulative mSWAT score.(Baseline up to 54 weeks)
- The time to maximal response in cumulative VASitch score.(Baseline up to 54 weeks)
- Change in Skindex-29 score at Week 12, Week 24, Week 36 and Week 54(Baseline up to 54 weeks)
- Change in Patient Benefit Index score at Week 12, Week 24, Week 36 and Week 54(Baseline up to 54 weeks)
研究者
Ellen Kim, MD
Principal Investigator
Abramson Cancer Center at Penn Medicine