Infusion of Panobinostat (MTX110) Into the Fourth Ventricle or Tumor Resection Cavity in Children and Adults with Recurrent Medulloblastoma: a Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of participants with grade 3 through grade 5 new neurological adverse events that are related to study drug
研究概览
简要总结
The purpose of this study is to establish the safety of infusions of panobinostat (MTX110) into the fourth ventricle of the brain or tumor resection cavity in patients with recurrent medulloblastoma and to assess the antitumor activity of simultaneous infusions of panobinostat (MTX110) into the fourth ventricle of the brain or resection cavity in patients with recurrent medulloblastoma based upon MRI scans and lumbar cerebrospinal fluid (CSF) cytology.
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
- 1 Year 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis: Patients with histologically verified medulloblastoma with recurrence or progression involving anywhere in the brain and/or spine.
- •Patient must have either measurable or evaluable tumor as assessed by MRI of the brain and total spine
- •An implanted catheter in the fourth ventricle or posterior fossa tumor cavity attached to a ventricular access device or agreement to have one placed.
- •A minimum of 7 days between last dose of systemic chemotherapy and/or radiation therapy and first infusion of chemotherapy into fourth ventricle
- •Life expectancy of at least 12 weeks in the opinion of the principal investigator
- •Lansky score of 50 or greater if ≤16 years of age or Karnofsky score of 50 or greater if > 16 years of age
- •Existing neurological deficits must have been stable for a minimum of 1 week prior to study enrollment
- •Patients must have recovered from the acute toxic effects of all prior anticancer chemotherapy
- •Adequate bone marrow function defined by peripheral absolute neutrophil count (ANC) ≥ 500/µL, platelet count ≥ 50,000/µL (transfusion independent), and hemoglobin ≥ 9.0 gm/dL (may receive red blood cells(RBC) transfusions)
- •Patient or patient's legal representative, parent(s), or guardian able to provide written informed consent.
- •Patient with prolonged QT interval on screening EKG will need cardiology consultation prior to enrollment
- •Patients with abnormal liver function tests (ALT, Aspartate Aminotransferase(AST),or total bilirubin) will need gastroenterology consultation prior to enrollment
排除标准
- •Enrolled in another treatment protocol
- •Has received another investigational or chemotherapy agent or radiation therapy within 7 days prior to intraventricular chemotherapy infusions
- •Evidence of untreated infection
- •Pregnant or lactating women
研究组 & 干预措施
Treatment with MTX110
干预措施: Treatment with MTX110 (Drug)
结局指标
主要结局
Number of participants with grade 3 through grade 5 new neurological adverse events that are related to study drug
时间窗: 4 months post intervention
Anew neurological deficit will be defined as new cranial neuropathy, change in level of consciousness, motor weakness, gait change or cerebellar finding (ataxia, dysmetria, dysdiadochokinesis) and will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
次要结局
- Change in disease progression as measured by lumbar CSF cytology(prior to first infusion; after last infusion (last infusion is about 6 weeks after the first infusion))
- Change in disease progression as measured by an MRI(prior to first infusion; after last infusion (last infusion is about 6 weeks after the first infusion))
研究者
David Ilan Sandberg
Professor
The University of Texas Health Science Center, Houston