JPRN-jRCTs041200030已完成2 期
A feasibility study of patient-proposed healthcare services with oral entrectinib in patients with ROS1-fusion-positive pediatric brain tumors - ROSE study
Kurimoto Michihiro0 个研究点目标入组 1 人开始时间: 2020年7月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
研究概览
简要总结
In this case, profiling by gene panel testing revealed a mutation in the driver gene, which led to patient-directed therapy for molecular targeted therapy. Although this therapy did not reduce the size of the target lesion, SD was achieved, which is an improvement over the clinical course expected from the original tumor grade. The safety profile was also acceptable, with no unexpected adverse events, no hematologic toxicity during the treatment period, and only grade 2 constipation.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 <= 15age old（—）
- 性别
- All
入选标准
- •1.Primary brain tumors with ROS1 gene fusions that are locally advanced; gene fusions are defined as those predicted to translate into a fusion protein with a functional ROS1 kinase domain, without a concomitant second oncodriver (e.g. known, activating mutations in EGFR, KRAS) as determined by a nucleic acid-based diagnostic testing method approved in Japan.
- •2.Patients who have no satisfactory treatment options for primary CNS tumors.
- •3.Performance status: PS (ECOG) 0-2 and minimum life expectancy of at least 4 weeks.
- •4.Age: Male or female from birth to age <=15 years.
- •5.Patients must have measurable or evaluable disease, as defined in RANO. Measurable disease is defined as bidimensionally contrast enhancing lesions with clearly defined margins by CT or MRI scan, with two perpendicular diameters of at least 10 mm, visible on two or more axial slices that are preferably, at most, 5 mm apart with 0-mm skip.
- •6.No prior treatment with approved or investigational ROS1 inhibitors.
- •7.Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment.
- •8.XRT/External Beam Irradiation: >=14 days after whole brain XRT;>=7 days after stereotactic radiation surgery.
- •9.Organ function;
- •i. ANC >= 1,000/microL;
- •ii. Hemoglobin >= 8.0 g/dL (without transfusion within 14 days of registration)
- •iii. Platelet count >= 75,000/microL (without transfusion)
- •iv. Bilirubin <= 1.5 mg/dl
- •v. ALT <= 3 x upper limit of normal (ULN)
- •vi. Serum creatinine <= ULN for age (5>=; 0.8mg/dl, 5-10; 1.2mg/dl and 10<=; 1.5mg/dl)
- •vii. ECG with QTcF <= 480 msec
- •10. Written informed consent: A signed informed consent and/or assent for study participation will be obtained from patients, parents or caregivers. (Written informed consent should be obtained from patients more than 7 years old.).
排除标准
- •1.Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
- •2. Active infection requiring systemic therapy.
- •3.Body temperature >= 38 degrees Celsius at registration.
- •4.Women during pregnancy, possible pregnancy or breast-feeding.
- •5.Continuous systemic use of immunosuppressant including steroid.
- •6.Uncontrolled diabetes mellitus or routine administration of insulin.
- •7.Congestive heart failure within 3 months or ejection fraction <= 50%.
- •8.Inadequately controlled hypertension.
- •9.Known congenital long QT syndrome.
- •10.Familial history of long QT syndrome.
- •11.Positive HBs antigen, positive HBs antibody or positive HBc antibody.
- •12.Positive HCV antibody.
- •13.Positive HIV antibody.
- •14.Pneumonitis, pulmonary fibrosis, or severe lung emphysema on chest CT.
- •15.Patients who were judged as inappropriate for entry in this study by the principal investigator or sub-investigators.
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