EUCTR2012-000072-42-AT进行中（未招募）1 期
A randomised phase IIb trial of bevacizumab added to temozolomide ± irinotecan for children with refractory/relapsed neuroblastoma – BEACON-Neuroblastoma Trial - BEACON-Neuroblastoma Trial: Bevacizumab, Temozolomide ± Irinotecan
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 224
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
- •Inclusion criteria for dinutuximab beta and topotecan randomisations:
- •Disease specific
- •Histologically proven neuroblastoma as per International Neuroblastoma Staging System (INSS) definition[1]
- •Relapsed or refractory neuroblastoma
- •oRelapsed: any relapsed or progressed high-risk neuroblastoma
- •oRefractory 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 bone marrow detectable disease only (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 and organ function
- •Performance status:
- •oLansky = 50%, Karnofsky = 50% or ECOG =3
- •(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 (within 72 hours of randomisation):
- •oNo 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)
- •oBone 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 (within 7 days of randomisation):
- •oSerum 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 (within 72 hours of randomisation): AST or ALT = 3.0 ULN and total bilirubin =1.5 ULN. In case of liver metastases, AST or ALT = 5 ULN and Total bilirubin = 2.5 ULN
- •Cardiac function, measured by echocardiogram within 4 weeks of randomisation or within 12 weeks if the patient has not received anthracyclines or cardiotoxics in between. 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 219
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Exclusion criteria for the dinutuximab beta and topotecan randomisations:
- •Previous treatment with temozolomide
- •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:
- •oAny study drug or component of the formulation
- •oPatients 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):
- •oTwo weeks from prior chemotherapy. One week from prior oral metronomic chemotherapy (i.e. oral etoposide or oral cyclophosphamide).
- •oSix weeks from prior craniospinal radiotherapy or MIBG therapy and two weeks from radiotherapy to the tumour bed. No washout is required for palliative radiotherapy
- •oEight weeks from prior high dose chemotherapy with autologous haematopoietic stem cell rescue
- •oThree months from prior allogeneic stem cell transplant, no ongoing treatment with immunosuppressive agents and no signs of =grade 2 acute graft versus host disease
- •o14 days or 5 half-lives (whichever occurs later) from last administration of an IMP in an IMP-trial.
- •o14 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
研究者
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