Dose Escalating Study to Evaluate the Tolerability, Efficacy and Safety of Amphinex 0.125 mg/kg or Lower in Amphinex-based PCI of Bleomycin in Patients With Local Recurrence or Advanced/Metastatic, Cutaneous or Sub-cutaneous Malignancies.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- To assess the combined tolerability and efficacy of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin
研究概览
简要总结
The primary goal of this extension study is to further investigate the tolerability and efficacy in a phase I setting in order to see whether lower doses than the initial study dose of 0.25 mg/kg bw Amphinex in Amphinex-based PCI of bleomycin will show a comparable or improved safety and tolerability profile in combination with comparable signs of efficacy.
详细描述
Use of Amphinex for the enhancement of Bleomycin at the intracellular target. The photosensitizer Amphinex is activated by Laser Light at 652 nm.
Superficial lesions (cutaneous or subcutaneous) was treated with the laser light after administration of Amphinex and Bleomycin according to time scheduled provided.
Safety and preliminary effect data where evaluated at a lower dose than explored in the preceeding dose escalating study with Amphinex.
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
- •• Male or female aged 18 years or above who have given written informed consent
- •Skin type I- IV according to the Fitzpatrick skin classification (see Appendix G)
- •With a diagnosis of local recurrence or advanced/metastatic, cutaneous or subcutaneous malignancy
- •Lesion measurement must not be done more than 2 weeks before the beginning of treatment. More than one field with lesion can be illuminated, but care must be taken to avoid overlap of the fields illuminated
- •Have discontinued any other investigational therapy or radiotherapy for at least 2 weeks prior to administration of Amphinex at the baseline visit, and have recovered from the acute effects of therapy
- •Have discontinued cytostatic or cytotoxic therapies with at least 6 half life cycles of the agent prior to administration of Amphinex at the baseline visit
- •Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale (see Appendix D)
- •Clinically assessed as eligible for bleomycin chemotherapy
- •Have a predicted life expectancy of at least 3 months
- •Geographic proximity that allow adequate follow-up
- •If female: have had childbearing potential either terminated by surgery, radiation, or menopause or attenuated by the use of an approved contraceptive method during and for 3 months after the trial
- •If male: have had reproductive potential either terminated or attenuated by the use of an approved contraceptive method during and for 3 months after the trial.
排除标准
- •Have received prior PCI
- •Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site
- •Planned surgery in first 28 days after treatment, except for planned surgical removal of the treated lesion
- •Planned dentist appointments in first 28 days after treatment
- •Anticancer therapy within the first 28 days after treatment
- •Therapy with drugs that induce light sensitivity (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea, hypoglycemic agents, thiazide diuretics, and griseofulvin) within the first 14 days after treatment
- •Co-existing ophthalmic disease likely to require slit-lamp examination within the first 28 days after treatment
- •History of hypersensitivity/anaphylactic reactions
- •Previous cumulative dose of Bleomycin received over 200 000 IE
- •Known allergy or sensitivity to photosensitisers
- •Known allergy to Cremophor
- •Known allergy to bleomycin
- •Conditions contraindicated for bleomycin treatment (lung infection, impaired pulmonary function)
- •Conditions that worsen when exposed to light (including porphyria)
- •Conditions associated with a risk of poor protocol compliance
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Amphinex based PCI of bleomycin
The photosensitiser Amphinex is activated by Laser to enhance the effect of Bleomycin
干预措施: Amphinex (Drug)
Amphinex based PCI of bleomycin
The photosensitiser Amphinex is activated by Laser to enhance the effect of Bleomycin
干预措施: Bleomycin (Drug)
Amphinex based PCI of bleomycin
The photosensitiser Amphinex is activated by Laser to enhance the effect of Bleomycin
干预措施: Laser (Device)
结局指标
主要结局
To assess the combined tolerability and efficacy of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin
时间窗: From Baseline to 3 months
Maximal pain during the procedure will be recorded immediately after the procedure on a 10 centimetre visual analogue scale (VAS). Pain will also be recorded 24 hours after the illumination and on day 4. The end-points of the VAS will be "no pain" and "unbearable pain A formal efficacy analysis is not appropriate for this trial. The response data will be documented by descriptive summary tables. No statistical comparison of dose levels will be done. Fluorescence measurements over time and lesion response evaluation according to RECIST (see Appendix E) will be presented for APT and PP stratified by dose level.
次要结局
- To evaluate the safety of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin.(From Baseline to 3 months)