NL-OMON50504招募中2 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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
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
- 2 至 17（—）
入选标准
- •Disease specific• Histologically proven neuroblastoma as per International
- •Neuroblastoma Staging System (INSS) definition • Relapsed or refractory
- •neuroblastomao 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 studyGeneral• Age >=1 to <=21
- •years• Informed consent from patient, parent or guardianPerformance and organ
- •function• Performance Status:o Lansky >= 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)• Life expectancy of >=12 weeks• Bone
- •marrow function (within 72 hours of randomisation):o No bone marrow disease: *
- •Platelets >= 75 x 10e9/L (unsupported for 72 hours) * ANC >= 0.75 x 10e9/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 10e9/L (no G-CSF for 72 hours)* Haemaglobin >= 8 g/dL (transfusions allowed) •
- •Renal function (within 7 days of randomisation):o 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 (within 72
- •hours of randomisation): AST and ALT <=3 ULN and total bilirubin <=1.5 ULN. In
- •case of liver metastases, AST and ALT <=5 ULN and total bilirubin <=2.5 ULN•
- •Cardiac function measured by echocardiogram within 4 weeks of randomization or
- •within 12 weeks if the patient has not received anthracyclines or cardiotoxics
- •in between, shortening fraction >=29% on echocardiogram • • Adequate lung
- •function: no dyspnea 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 male patients must agree
- •to use condoms during the study 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
- •(neuronen, perifere pijn vezels, huid) aanwezig is. Dinut
排除标准
- •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:o Any study drug or component of the formulation
- •o Patients with mild previous hypersensitivity reactions to anti-GD2 antibodies
- •may be included, but those with severe (or G4) hypersensitivity reactions to
- •anti-GD2 antibodies will be excluded• Clinically significant neurological
- •deficit, uncontrolled seizures or objective peripheral neuropathy ( >grade 2).
- •(Unresolved neurological deficits from 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):o Two weeks from
- •prior chemotherapy. One week from prior oral metronomic chemotherapy (i.e. oral
- •etoposide or oral cyclophosphamide)o Six weeks from prior craniospinal
- •radiotherapy or MIBG therapy and two weeks from radiotherapy to the tumour bed.
- •No washout is required for palliative radiotherapyo Eight weeks from prior high
- •dose chemotherapy with autologous haempoietic stem cell rescue o Three months
- •from prior allogeneic stem cell transplant, no ongoing treatment with
- •immunosuppressive agents and no signs of >=grade 2 acute graft versus host
- •diseaseo 14 days or 5 half-lives (whichever occurs later) from last
- •administration of an IMP in an IMP-trialo 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 compliancet geen anthracyclines of
研究者
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