Calcium Electroporation for Treatment of Cutaneous Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Tumor response
研究概览
简要总结
The purpose of this study is to evaluate the effect of calcium electroporation on cutaneous metastases, and compare calcium electroporation with standard treatment: electrochemotherapy.
详细描述
Double-blinded phase II clinical study. We will compare the effect of calcium electroporation for the treatment of cutaneous metastases with standard treatment: electrochemotherapy with intratumoral injection of bleomycin. Separate randomisation will be performed and the lesions will be treated with either intratumoral injection of calcium or bleomycin. It is a once only treatment and the patients will be followed up for 6 months.
It is a non-inferiority study and we accept a difference in response on 15%.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patient and treating doctor only knew the size of the treated tumor, and the injection volume, but not the content of the syringe (either calcium or bleomycin).
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
- •Age > 18 years.
- •Histological confirmed cutaneous metastases of any histology.
- •cutaneous metastases between 0,5 to 3cm, available to electroporation.
- •Patient should have been offered standard treatment.
- •At least 2 weeks since chemotherapy or radiotherapy.
- •Performance status >2 (ECOG).
- •Life expectancy >3 months.
- •platelet count > 50 mia/l.
- •International Normalized Ratio (INR) <1,
- •Men and women of reproductive age must use effective contraception during the study.
- •Patient should be able to understand participants information.
- •Signed, informed consent.
排除标准
- •Previously treatment with bleomycin > 200.000 Units/m
- •Allergy to bleomycin.
- •Clinically significant coagulopathy.
- •Pregnancy or lactation.
- •Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.
研究组 & 干预措施
Calcium electroporation
The metastases will be treated with intratumoral injection of calcium chlorid followed by electrotransfer.
It is a once-only treatment. Calcium chlorid concentration: 9mg/ml. Total dose: 0,5ml/cm3 tumor volume.
干预措施: Calcium electroporation (Drug)
Electrochemotherapy with bleomycin
The metastases will be treated with intratumoral injection of bleomycin followed by electrotransfer.
It is a once only treatment. bleomycin concentration: 1000 IU/ml. Total dose: o,5 ml/cm3 tumor volume.
干预措施: Electrochemotherapy with bleomycin (Drug)
结局指标
主要结局
Tumor response
时间窗: After 6 months
Response evaluated by "Response Evaluation Criteria in Solid Tumors" (RECIST) guidelines version 1.1.
次要结局
- Adverse events to calcium electroporation(After 6 months)