JPRN-jRCT2051190044进行中（未招募）2 期
Phase 2 clinical trial of boron neutron capture therapy for recurrent high-grade meningioma using SPM-011 and BNCT30 - BNCT for high-grade meningioma
Miyatake Shin-ichi0 个研究点目标入组 18 人开始时间: 2019年9月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 75age old（—）
- 性别
- All
入选标准
- •1.KPS at recurrence is 60 percent or more.
- •2.Target lesion is intracranially localized by contr ast-enhanced images.
- •3.Recurrence or progression is confirmed by hea d CT or MRI.
- •4.Lesions seemed to be unresectable.
- •5.All target lesions should be treatable using max imum available collimator.
- •6.Histologically confirmed as high-grade meningioma (WHO grade 2 or 3) at initial diagnosis or at recurrence
- •7.Previous radiotherapy of target lesion should be equivalent to less than 65Gy by daily 2Gy fractionated X-ray treatment.
- •8.Previous radiotherapy should be started at leas t 90 days prior to screening.
- •9.One or more measurable lesions should be confined into neutron irradiation field. If all target or non-target lesions are included in one neutron irradiation field, the case can be included.
- •10.Patients with bone marrow, liver, kidney function at screening defined as below. Within 14 days just prior to screening, any supportive treatment possibly affect those functions should not be allowed such as G-CSF, blood transfusion and so on.
- •Kidney function:
- •Serum creatinine 1.2 mg/dL or less in male and 1.0 mg/dL or less in female
- •Liver function:
- •AST less than 5-times institutional upper normal limit
- •ALT less than 5-times institutional upper normal limit
- •Bone marrow function:
- •Hemoglobin 8.0 g/dL or more
- •Platelet count 80,000 /microlitter or more
- •Leukocyte count 2,500 /microlitter or more
- •Neutrophil count 1,500 /microlitter or more
- •11. Patients without clinically significant abnormalities in ECG
- •12. Patients without clinically significant abnormalities in Chest X-ray
排除标准
- •1.Main target lesions are in infratentorial regions.
- •2.Patients with other prior or concurrent malignancy within the preceding 5 years, except cured-state carcinoma in situ or skin cancer, are not eligible.
- •3.Patients who have extra-cranial metastasis
- •4.Patients who have contrast enhanced lesions out-side of maximum available collimator
- •5.Patients who have meningeal dissemination
- •6.Active infection needs to be treated systemically
- •7.Severe intercurrent medical conditions as follows;
- •Uncontrolled diabetes mellitus,
- •Uncontrolled hypertension,
- •Chronic pulmonary disease such as COPD, interstitial pneumonia, pulmonary fibrosi s, severe pulmonary emphysema,
- •Renal disease such as chronic renal failure, acute renal failure, nephrotic syndrome,
- •Heart disease corresponds to grade III or IV in NYHA cardiac function classification,
- •Other serious complications.
- •8.Patients with phenylketonuria
- •9.Patients with hereditary fructose intolerance
- •10.Patients who have severe allergic reaction to some drugs or contrast-agent including skin eruption, anaphylaxis and serum disease
- •11.Myocardial infarction, unstable angina, uncontrollable arrhythmia to develop within 6 months prior to scheduled BNCT
- •12.Patients who were treated with anti-cancer agents within 4 weeks prior to scheduled BNCT
- •13.Patients who received the surgery for brain tumor extirpation within 30 days prior to scheduled BNCT
- •14.Patients who were treated with unapproved drug within 4 weeks prior to scheduled BNCT or patients who have currently enrolled or have the willingness to be enrolled to other clinical trial
- •15.Patients impossible to be used with contrast agent for MRI due to cardiac pacemaker, metal implant, cochlear implant or allergic reaction
- •16.Female patients desiring pregnancy during observation period of this clinical trial or female patients during pregnancy or breastfeeding. Male or female patients who have the possibility of the pregnancy should keep adequate contraception using birth control pills, condoms, vasectomy, tubal ligation, contraceptive diaphragms, intrauterine devices, spermicidal agents and so on.
- •17.Patients who are judged as difficult to participate in this trial due to mental disease or psychiatric symptoms, or patients taking major tranquilizer
- •18.Patients with uncontrolled epilepsy defined as below;
- •Concurrent frequent hospitalization due to epileptic state and/or clinical symptoms, or treatment need for persistent seizure or symptoms
- •Necessary for nursing care due to trouble in daily life
- •19.Patients who were administrated with G-CSF or blood transfusion within 14 days just prior to screening
- •20.Previous treatment history of BNCT
研究者
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