EUCTR2020-000670-22-GB进行中（未招募）1 期
A Phase I/II Dose-escalation and Expansion Cohort Trial of Intracerebroventricular Radioimmunotherapy Using 177Lu-DTPA-omburtamab in Pediatric and Adolescent Patients with Recurrent or Refractory Medulloblastoma - 177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
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
- •Patients must satisfy all of the following criteria at the Screening Visit, unless otherwise stated:
- •1. Histologically confirmed diagnosis of medulloblastoma.
- •2. Available molecular classification according to World Health Organisation 2016 classification (Louis et al. 2016), as follows:
- •a. SHH, Group 3, or Group 4
- •3. Recurrent or refractory to frontline therapy, defined as:
- •a. For Part 1 only: Recurrent (maximum of 2 recurrences) or refractory to frontline therapy. Prior frontline or second-line therapy may involve surgery, craniospinal irradiation, stereotactic radiosurgery, and multi-agent chemotherapy regimens.
- •b. For Part 2 only: Recurrent (maximum of 1 recurrence) or refractory to frontline therapy. Patients with recurrent disease must have received second-line chemotherapy for progressive disease. Prior frontline or second-line therapy may involve surgery, craniospinal irradiation, stereotactic radiosurgery, and multiagent chemotherapy regimens.
- •4. Be in cytological or radiographic remission, have residual disease, multifocal recurrent disease, or pure leptomeningeal disease.
- •5. Performance status score of 50 to 100, inclusive, on the Lansky [<16 years] or Karnofsky [=16 years] scales.
- •6. Aged 3 to 19 years, inclusive, at the time of the first planned dose of trial treatment.
- •7. Life expectancy of at least 3 months, as judged by the investigator.
- •8. Acceptable hematological status prior to first dosing (hematological support is allowed if administered at least 1 week before administration of 177Lu-DTPA-omburtamab), defined as:
- •a. Hemoglobin =8 g/dL
- •b. White blood cell count =1000/µL.
- •c. Absolute neutrophil count =1000/µL
- •d. Platelet count =75 000/µL.
- •9. Acceptable liver function prior to first dosing, defined as:
- •a. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =5 × upper limit of normal (ULN)
- •b. Bilirubin =1.5 × ULN.
- •10. Acceptable kidney function prior to first dosing, defined as:
- •a. Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m2, calculated by the 2009 revised Bedside Schwartz Equation.
- •11. Written informed consent from legal guardian(s) and/or child obtained in accordance with local regulations. Pediatric patients must provide assent as required by local regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 14
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Obstructive or symptomatic communicating hydrocephalus as determined by Ommaya patency/CSF flow assessment.
- •2. Residual disease (nodular or linear) measuring >5 mm in the smallest diameter.
- •3. Ventriculoperitoneal (VP) shunts without programmable valves. Ventriculo-atrial or ventriculo-pleural shunts.
- •4. Grade 4 nervous system disorder. Hearing loss or stable neurological deficits due to brain tumor are allowed.
- •5. Uncontrolled life-threatening infection.
- •6. Received radiation therapy, systemic or intrathecal cytotoxic chemotherapy, or intrathecal immunotherapy (corticosteroids not included) less than 3 weeks prior to the Screening Visit.
- •7. Received any prior anti-B7-H3 treatment.
- •8. Non-hematologic organ toxicity Grade 3 or above; specifically, any renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity.
- •9. Females of childbearing potential who are pregnant, breast feeding, intend to become pregnant, or are not using highly effective contraceptive methods or males who are not using highly effective contraceptive methods.
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