Pilot Study of the Application of Palliative Treatment in Children With Brain Stem Glioma and Recurrent High-grade Tumors in the Central Nervous System With the Nanomaterial Platinum Acetylacetonate (1% wt) Supported by Sol-gel Technology Functionalized Titania (NPt-Ca)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in the quality of life using the PedsQL Cancer Module©
研究概览
简要总结
This Protocol is a pilot, clinical interventional study to selected patients between five and fourteen years of both sexes, carriers of the diagnosis of glioma brain stem and high grade recurrent in the central nervous system tumors, in whom there has been no response to conventional-based surgery/radiation/chemotherapy treatment or whose location does not allow treatment with conventional measures, and that already have an indication for a neurosurgical palliative procedure. It will be a close pharmacovigilance on possible adverse effects related to the nanomaterial based on the profile of cisplatin (chemotherapeutic platinum derivative), since documented toxicity data are not counted for NPt-Ca. Quality of life will be documented with PedsQL Cancer Module© and tumor size by magnetic resonance brain images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathological diagnosis or MRI of the brain stem or tumor of recurrent high-grade glioma.
- •Indication of palliative surgical treatment by neurosurgery.
- •Good general condition, enabling the realization of surgical treatment.
- •Scale Lansky > 20)
- •conventional treatment (surgery, radiotherapy, and chemotherapy) failed or not applicable to the patient.
排除标准
- •Patients with emerging infectious diseases or fever in the last 72 hours prior to placement of the NPt-Ca.
- •Patients whose parents/carers do not authorize expressly the realization of procedure with knowledge of its experimental nature, are not agreed or established their commitment to meet follow-up parameters established by this Protocol.
- •Patients with surgical complications prior to placement of the NPt-Ca.
- •Patients in which the size and location of the lesion do not allow their surgical approach or an increase in volume by infiltration of the lesion with 3 ml of volume of NPt-Ca.
- •Patient whose neurological condition do not allow the implementation of MRI without anesthesia.
研究组 & 干预措施
glioma brain stem
干预措施: Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania (Drug)
high grade recurrent brain tumor in the central nervous system
干预措施: Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania (Drug)
结局指标
主要结局
Change in the quality of life using the PedsQL Cancer Module©
时间窗: Preoperative and at 1.3, 6, 12, 18 and 24 months.
Measures of the change of quality of life pre and after the administration of NPt-Ca using the questionnaire PedsQL Cancer Module©
Change in tumor size
时间窗: Immediate, 1, 2, 3, 6, 8, 10, 12, 18 and 24 months.
Change in tumor size after the administration of NPt-Ca using volumetric measures on the brain magnetic resonance.
次要结局
未报告次要终点
研究者
Daniel Eduardo Alvarez Amado
Researcher in the Neurology Department
Hospital Infantil de Mexico Federico Gomez