EUCTR2016-001577-33-ES进行中（未招募）1 期
Phase I Trial of DNX-2401 for Diffuse Intrinsic Pontine Glioma newly diagnosed in pediatric patients.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Informed consent OF PATIENT OR PARENTS
- •2. Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
- •3. Age 1 - 18 years
- •4. Negative pregnant blood test in case of fertile women (A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- •5. Patient newly diagnosed of DIPG in MRI
- •6. Lansky Performance Status = 70 before inclusion
- •7. Lesion considered by the investigator to be accessible for stereotactic biopsy. Lesion location will allow injection without entrance of virus in the ventricular system.
- •8. No previous treatment for DIPG
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Severe infections or intercurrent medical conditions including, but not limited to, severe renal, hepatic, heart or bone marrow failure, that, on investigator´s criteria, do not allow the inclusion. Patients must be afebrile at baseline [i.e., < 38 degrees (Cº)].
- •2. Investigational medication in the previous 30 days.
- •3. Subjects with immunodeficiency, autoimmune conditions or active hepatitis.
- •4. Any medical or psychological condition that might interfere with the subject's ability to participate if older than 16 years or parents ability when younger than 16, or give informed consent or would compromise the patient’s ability to tolerate therapy or any disease that will obscure toxicity or dangerously alter drug metabolism.
- •5. Tumor with multiple locations or doubt in MRI of a DIPG.
- •6. Pregnant or breast-feeding females will be excluded, due to the risk for the fetal development of a recombinant virus containing genes related to cellular growth and differentiation.
- •7. Severe bone marrow hypoplasia.
- •8. AST and/or ALT > 3 times over upper normal laboratory level
- •9. Neutrophils < 1 x 109/L
- •10. Thrombocytes = 100 x 109/L
- •11. Hemoglobin < 9g/dl
- •13. Patients with Li-Fraumini Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways.
- •14. Vaccinations of any kind within 30 days prior to DNX-2401 administration.
- •15. Transfusions or medications (G-CSF) to treat pancytopenia or other hematological conditions within 28 days of baseline.
研究者
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