A Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Feasibility - DaRT seed placement
研究概览
简要总结
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of recurrent Glioblastoma
详细描述
This is a Prospective Open label Single arm Multi-center interventional study. The study is designed to evaluate the Feasibility and Safety of DaRT seeds for the treatment of recurrent Glioblastoma.
A total of 10 subjects will be enrolled.
Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion and will return for a follow up visit every 2 months (+/- 7 days ) up to 12 months (4 ,6 , 8, 10 and 12 ). Survival F.U (after visit 11) will be done via phone calls every 2-3 months until (1) the start of new anti-cancer treatment, (2) disease progression or (3) death, whichever occurs first.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥ 18 and ≤ 85 years of age
- •Patients must have histologically confirmed diagnosis of WHO grade IV glioblastoma (including variants such as gliosarcoma, giant cell glioblastoma).
- •Single, gadolinium-enhancing tumor recurrence ≤ 3cm in maximum diameter
- •Patient not amenable for surgical resection due to any of the following but not limited reasons: patient refusal, medically ineligible, surgically too high risk due to tumor location in a deep and/or eloquent location.
- •Prior history of central nervous system (CNS) radiation (standard dose) with 50.4-60 Gy delivered in 1.8 Gy-2.0 Gy fractions with concurrent temozolomide (if the patient has received a non-standard fractionation or radiation dose, such as 40 Gy in 15 fractions.
- •Patients must have a time interval ≥4 months between completion of prior radiation and trial registration and have tumor progression per RANO criteria
- •Patients must have a measurable disease per RANO criteria
- •Estimated life expectancy is more than 6 months
- •Target lesion amenable for coverage by the DaRT sources
- •Patient must either have had recent subtotal surgery/biopsy following tumor recurrence (at least 6 weeks from trial registration) or must have shown unequivocal radiographic evidence for tumor progression by contrast-enhanced MRI scan within 21 days prior to trial registration. If surgery was performed, must have a post-operative MRI scan within 21 days prior to trial registration.
- •Patients have recovered from prior therapy side effects and must be at least 4 weeks post administration of chemotherapies or investigational agents with the exception of nitrosureas (such as Carmustine, Fotemustine, Lomustine) which requires 42 days of washout.
- •Karnofsky performance score (KPS) of at least 60 documented within 14 days prior to trial registration
- •Patients must have adequate biological parameters as demonstrated by the following blood counts at initial screening obtained ≤ 14 days prior to starting treatment Absolute neutrophil count (ANC) ≥ 1.5 × 109/L Platelet count ≥ 100,000/mm3 (80 × 109/L) Hemoglobin (Hgb) ≥ 9 g/dL.
- •Patients must have the following blood chemistry levels at initial screening obtained ≤ 14 days prior to starting treatment AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN) Total bilirubin ≤ 1.5 × ULN
- •Effective contraception must be used by both male and female patients while on the study and for up to 3 months following treatment
- •Patient must have been informed about the nature of the study, and must have agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities
排除标准
- •Medical contraindication to MRI (cardiac devices are allowed if MRI compatible)
- •More than 3 relapses per RANO criteria
- •Acquired and or genetic clinical bleeding tendency
- •Suspicious of infratentorial or leptomeningeal or intraventricular disease
- •Concomitant chemotherapy or any other systemic therapy not allowed in the protocol
- •Recent or current (within 6 weeks) therapy with VEF or a VEGFR inhibitor
- •Immunocompromised state due to either transplant or AIDS
- •Prior allergic reaction to the study drugs
- •History of hypertensive crisis or hypertensive encephalopathy
- •Uncontrolled hypertension (defined as either >150 mm/Hg for systolic and >90mm/Hg for diastolic)
- •History of a non-healing wound, ulcer, gastrointestinal bleed (> grade 3), traumatic injury, or bone fracture within 90 days prior to registration Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT
- •High probability of protocol non-compliance (in opinion of investigator)
- •Pregnancy or lactation
- •Collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
研究组 & 干预措施
Experimental: DaRT seeds
DaRT sources are inserted into the tumor according to a pre determined plan. The delivery of the DaRT Sources into the tumor is done by using a designated Alpha DaRT Applicator .
干预措施: Device :DaRT seeds (Device)
结局指标
主要结局
Feasibility - DaRT seed placement
时间窗: From day 0 until 12 months
Feasibility will be determined according to the rate of successful placement of Alpha DaRT sources into brain tumors.
Safety - Adverse events
时间窗: From day 0 until 12 months
Safety will be determined according to incidence of acute grade 3 or greater unanticipated Adverse Events (AE) according to CTCAE v5.0 criteria
次要结局
- Toxicity profile(within 4 weeks of completion of postoperative radiotherapy)
- Radiographic local tumor control(from 1 month following surgery and onwards)
- Rate of pseudo-progression at first post-implant scan(1 month following surgery)
- Overall survival(up to 12 months post implant)