Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Clinical Measure of Lesion Size.
研究概览
简要总结
By applying short electric pulses to cells, the cell membranes can become permeabilised (electroporation). This can be used augment the effect of chemotherapy, by providing direct access to the cell cytosol. For the drug bleomycin, the enhancement of effect is several hundred fold, enabling once-only treatment. We wish to offer electrochemotherapy to breast cancer patients suffering from chest wall recurrences that are ulcerated or painful and where other treatments have failed.
详细描述
Electrochemotherapy for chest wall recurrence of breast cancer. MD, Ph.D. student, Louise Wichmann Matthiessen, has been employed in 2008 to perform this study. She plans to complete her training as specialist in clinical oncology subsequently, and will thus be able to follow up the work after completion of her Ph.D. The study aims at giving palliation to patients who are suffering from painful, ulcerated metastases to the chest wall in a situation where other treatments have failed.
Inclusion criteria: Chest wall recurrence of breast cancer; all other modalities have failed or patients does not wish to receive them (e.g. chemotherapy); symptomatic relief is needed; WHO performance status 0-2; normal coagulation parameters, normal kidney and renal function; written, informed consent. Lesions totalling over 3 cm in diameter. Patient recruitment: 28 patients are to be recruited.
Treatment: Patients will be treated in general anesthesia (inhaling max. 30 % oxygen), and a standard dose of bleomycin (15.000 IU/ m2) will be given intravenously. Electric pulses will be administered using a square wave electroporator (IGEA, Carpi, Italy). Needle and plate electrodes are used in order to treat the affected area efficiently. Eight pulses at a frequency of 5 kHz will be used for each application of the electrodes. In this way, a large area can be treated within a short time. Post treatment, the area will be covered by dry dressings, as are standardly used.
The patients will be seen at 2, 4, and 8 weeks post treatment, and re-treatment can be administered up to three times in case there are areas which have not been insufficiently treated in the first round. Lung function will be followed by measurement of DLCO (carbon monoxide diffusion capacity).
The patients will furthermore be followed up to 1 year after treatment in monthly intervals, and after 1 year on a yearly basis for up to 5 years.
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 proven cancer of the breast.
- •Progressive and/or metastatic disease.
- •No further standard treatment for the patient available or the patient does not wish to receive the offered standard treatment.
- •If Endocrine therapy: Progression in cutaneous lesions.
- •If treatment with trastuzumab (Herceptin)can continue this treatment if there is no regression in cutaneous lesions.
- •At least 2 weeks since last chemotherapy, patients treated with Navelbine (Vinorelbine), Capecitabin (Xeloda) or weekly Paclitaxel (Taxol)can continue this treatment if there is no regression in cutaneous metastases.
- •Malignant cutaneous or subcutaneous lesion to be treated ≥ 3 cm.
- •WHO performance ≤
- •Life expectancy of at least 3 months.
- •Platelets ≥ 50 mia/l, pp ≥ 40, APTT in normal area. Medical correction is allowed.
- •Sexual active men and women must use safe anticonceptive during and up to 6 month after last treatment.
- •Written informed consent must be obtained according to the local Ethics committee requirements.
排除标准
- •Acute lung infection
- •Previous bleomycin treatment exceeding 200.000 Units/m
- •Known hypersensitivity to any of the components of the treatment.
- •Known hypersensitivity to any of the components used in the planned anesthesia.
- •Pregnant or lactating women. In fertile women this is ensured by measuring HCG in blood.
- •Treatment with granulocyte colony stimulating factor (G-CSF) or other cytokines.
结局指标
主要结局
Clinical Measure of Lesion Size.
时间窗: up to one year
Response was evaluated clinical using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and documented with digital photography. Number of patients with objective response evaluated with clinical measure of lesion size
次要结局
- Participants With Objective Response Evaluated With PET/CT(3, weeks, 8 weeks, and up to 6 months after treatment)
- Safety and Toxicity(up to 1 year)