临床试验/2024-518931-12-00

2024-518931-12-00招募中2 期

BEACON: A randomised phase IIb trial of BEvACizumab added to Temozolomide ± IrinOtecan for children with refractory/relapsed Neuroblastoma

The University Of Birmingham19 个研究点分布在 5 个国家目标入组 122 人开始时间: 2024年11月13日最近更新: 2024年11月25日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方: The University Of Birmingham
入组人数: 122
试验地点: 19
主要终点: Best response (Complete Response [CR], or Partial Response [PR](Brodeur et al. 1988) at any time during the first 6 cycles of trial treatment

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To test whether bevacizumab added to a backbone chemotherapy regimen (temozolomide, irinotecan, temozolomide or topotecan-temozolomide) demonstrates activity in children with relapsed or refractory neuroblastoma
To test whether the addition of irinotecan to temozolomide increases the activity of chemotherapy in children with relapsed or refractory neuroblastoma
To test whether the addition of topotecan to temozolomide increases the activity of chemotherapy in children with relapsed or refractory neuroblastoma

入排标准

年龄范围: 0 years 至 17 years（0-17 Years）
接受健康志愿者: 是

入选标准

•Histologically proven neuroblastoma as per International Neuroblastoma Staging System (INSS) (Brodeur et al. 1988) definition
•Cardiac function, measured using echocardiogram prior to 4 weeks of randomisation date or 12 weeks if patient has not received anthracyclines or cardiotoxics. Shortening fraction ≥29% on echocardiogram
•Adequate lung function; no dyspnoea at rest and pulse oximetry > 94% in room air
•Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to initiation of treatment. Sexually active women of childbearing potential must agree to use acceptable and appropriate contraception during the study and for at least 6 months after the last study treatment administration. Sexually active males patients must agree to use condom during the study and for at least 6 months after the last study treatment administration.
•Availability and willingness to place a double central venous access if needed for trial treatment and supportive care in case of treatment with chemo-immunotherapy
•Relapsed or refractory neuroblastoma o Relapsed: any relapsed or progressed high-risk neuroblastoma o Refractory high risk disease: Lack of adequate response to frontline therapy that precludes the patient from proceeding to consolidation therapies (e.g. myeloablative chemotherapy)
•Measurable disease by cross sectional imaging (RECIST) or evaluable disease (uptake on MIBG scan with or without bone marrow histology). Patients with only bone marrow detectable disease (bone marrow aspirate or trephine) are NOT eligible for the study
•Age ≥1 to ≤21 years
•Informed consent from patient, parent or guardian
•Performance Status: o Lansky ≥ 50%, Karnofsky ≥ 50% or ECOG ≤3 o (Patients who are unable to walk because of paralysis, but who are able to sit upright unassisted in a wheelchair, will be considered ambulatory for the purpose of assessing performance score)
•Bone marrow function (prior to 72 hours of planed randomisation date): o No bone marrow disease:  Platelets ≥ 75 x 109/L (unsupported for 72 hours)  ANC ≥ 0.75 x 109/L (no G-CSF support for 72 hours)  Haemoglobin > 7.5 g/dL (transfusions allowed) o Bone marrow disease:  Platelets ≥ 50 x109/L (unsupported for 72 hours)  ANC ≥0.5 x 109/L (no G-CSF for 72 hours)  Haemoglobin > 7.5 g/dL (transfusions allowed) Dinutuximab beta arm only: • Bone marrow function (within 72 hours of randomisation): o No bone marrow disease:  Platelets ≥75 x 109/L (unsupported for 72 hours)  ANC ≥ 0.75 x109/L (no G-CSF support for 72 hours)  Haemoglobin ≥ 8 g/dL (transfusions allowed) o Bone marrow disease:  Platelets ≥ 50 x109/L (unsupported for 72 hours)  ANC ≥ 0.5 x 109/L (no G-CSF for 72 hours)  Haemoglobin ≥ 8 g/dL (transfusions allowed)
•Renal function (prior to 7 days of randomisation date):Serum creatinine ≤ 1.5 ULN for age, if higher, a calculated GFR (radioisotope or 24 hour urine calculated creatinine clearance) must be ≥ 60 ml/min/1.73 m2
•Liver function (prior to 72 hours of randomisation date): AST or ALT ≤3 ULN and total bilirubin ≤1.5 ULN. In case of liver metastases, AST or ALT ≤5 ULN and total bilirubin ≤2.5 ULN.

排除标准

•Previous treatment with temozolomide drugs
•Current chronic intestinal inflammatory disease/bowel obstruction (Bevacizumab randomisation only)
•Known intolerance to galactose and fructose, lactase deficiency, and/or defect of absorption of galactose and fructose (Bevacizumab randomisation only)
•Pregnant or lactating patient
•Any uncontrolled medical condition that poses an additional risk to the patient (i.e. haemoptysis, non-healing, bone fracture, wound/ulcer)
•Low probability of treatment compliance
•Previous treatment with chemotherapy in combination with anti-GD2 directed therapy (“chemo-immunotherapy”) with any anti-GD2 antibody. Prior treatment with anti-GD2 directed therapy alone with/without cytokines is allowed provided a 4 week wash-out period is met
•Known hypersensitivity to: o Any study drug or component of the formulation
•Patients with mild previous hypersensitivity reactions to anti-GD2 antibodies may be included, but those with severe (or G4) hypersensitivity reactions to antiGD2 antibodies will be excluded Clinically significant neurological deficit, uncontrolled seizures or objective peripheral neuropathy (>grade 2). (Unresolved neurological deficits from previous spinal cord compression are acceptable)
•Uncontrolled infection
•Inadequate recovery from prior surgery with no ongoing ≥Grade 3 surgical complications. For core biopsies, no less than 24 hours; for open excisional biopsies, no less than 48 hours; for major surgery, no less than 2 weeks Patient less than (at point of planned date of randomisation):  Two weeks from prior chemotherapy. One week from prior oral metronomic chemotherapy (i.e. oral etoposide or oral cyclophosphamide).Six weeks from prior craniospinal radiotherapy or MIBG therapy and two weeks from radiotherapy to the tumour bed. No washout is required for palliative radiotherapy  Eight weeks from prior high dose chemotherapy with autologous haematopoietic stem cell rescue  Three months from prior allogeneic stem cell transplant, no ongoing treatment with immunosuppressive agents and no signs of ≥grade 2 acute graft versus host disease  14 days or 5 half-lives (whichever occurs later) from last administration of an IMP in an IMP-trial.  14 days or 5 half-lives (whichever occurs later) from last administration of any other biological/targeted anticancer agent
•Bleeding metastases (Patients with CNS metastases can be enrolled as long as the metastases are not bleeding)  Pregnant or lactating patient  Any uncontrolled medical condition that poses an additional risk to the patient  Low probability of treatment compliance
•History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e. in the absence of therapeutic anticoagulation) (Bevacizumab randomisation only)
•History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months prior to study enrolment (Bevacizumab randomisation only)

结局指标

主要结局

Best response (Complete Response [CR], or Partial Response [PR](Brodeur et al. 1988) at any time during the first 6 cycles of trial treatment

For the bevacizumab part 2 only: Progression-free survival (PFS)

次要结局

Safety of the regimens: Incidence and severity of Adverse Events (AE)
PFS
Event-free survival (EFS)
Overall survival (OS)

研究者

发起方

The University Of Birmingham

申办方类型

Educational Institution

责任方

Principal Investigator

主要研究者

Trial Coordinator

Scientific

The University Of Birmingham

研究点 (19)

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