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New treatment option for Neuroblastoma Recurrent
Official title 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma
ClinicalTrials.gov ID: NCT04903899
What this study is testing
What is 177Lu-DOTATATE?
177Lu-DOTATATE is an investigational medicine, being studied as a potential treatment for neuroblastoma recurrent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The LuDO-N Trial is a multi-centre phase II clinical trial on 177Lu-DOTATATE treatment of recurrent or relapsed high-risk neuroblastoma in children. The LuDO-N Trial builds on the experience from the previous LuDO Trial and utilises an intensified dosing schedule to deliver 2 doses over a 2-week period, in order to achieve a maximal effect on the often rapidly progressing disease.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathology 1.1. Histologically confirmed diagnosis of neuroblastoma 1.2. Immunohistochemical staining for somatostatin receptors (SSTR) performed from...
- Relapsed or primary refractory high-risk neuroblastoma: INSS stage 4 disease or INRGSS stage M disease
- Age \>18 months at the time of enrolment into this study
- Life expectancy of greater than 3 months
- Performance Status 5.1. Karnofsky \> 50% (for patients \> 12 years of age) 5.2. Lansky \> 50% (for patients ≤ 12 years of age)
You likely can't join if
- Not fit enough to undergo proposed study treatment, as assessed by national PI, considering precautions defined in the latest version of the...
- Pregnant or lactating patient
- Concurrent treatment with any anti-tumor agents
- Prior treatment with other radiolabeled somatostatin analogues
- Hypersensitivity to any component of the investigational drug 177Lutetium-DOTATATE
- Treatment with long-acting somatostatin analogues within 30 days, or with short-acting somatostatin analogues within 24 hours prior the...
See the full eligibility criteria
- Pathology 1.1. Histologically confirmed diagnosis of neuroblastoma 1.2. Immunohistochemical staining for somatostatin receptors (SSTR) performed from primary tumor tissue when available
- Relapsed or primary refractory high-risk neuroblastoma: INSS stage 4 disease or INRGSS stage M disease
- Age \>18 months at the time of enrolment into this study
- Life expectancy of greater than 3 months
- Performance Status 5.1. Karnofsky \> 50% (for patients \> 12 years of age) 5.2. Lansky \> 50% (for patients ≤ 12 years of age)
- Prior treatment 6.1. Two-week washout from any prior treatment 6.2. Patients must have recovery of hematological toxicity following previous therapy 6.3. Adequate recovery from major surgery prior to receiving study...
- Diagnostic imaging 7.1. Uptake in the primary tumor or metastatic tumour deposits on 68Ga-DOTATATE PET/CT at least higher than the liver uptake and performed within two months prior to registration 7.2. 123I-mIBG...
- Laboratory requirements to be performed within 7 days prior to commencing trial treatment 8.1. Hematology: 8.1.1. Hemoglobin, If Hb is \ 1.0 x 109/L 8.1.3. Absolute Platelets \> 50 x 109/L 8.2. Biochemistry: 8.2.1...
- Peripheral blood stem cells (PBSC) 9.1. A minimum of 2 x106 CD34+ cells/kg (optimally 6 x106 CD34+ cells/kg) must be available for each study subject prior to registration
- Written informed consent from patient and/or parent(s) or legal guardian(s) in accordance with national regulations, prior to registration or any trial-related screening procedures
- Not fit enough to undergo proposed study treatment, as assessed by national PI, considering precautions defined in the latest version of the 177Lutetium-DOTATATE SmPC.
- Pregnant or lactating patient
- Concurrent treatment with any anti-tumor agents
- Prior treatment with other radiolabeled somatostatin analogues
- Hypersensitivity to any component of the investigational drug 177Lutetium-DOTATATE
- Treatment with long-acting somatostatin analogues within 30 days, or with short-acting somatostatin analogues within 24 hours prior the administration of 177Lutetium-DOTATATE
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Copenhagen, Denmark
- Vilnius, Vilnius County, Lithuania
- Utrecht, Utrecht, Netherlands
- Oslo, Oslo, Norway
- Stockholm, Stockholm County, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Copenhagen, Denmark; Vilnius, Vilnius County, Lithuania; Utrecht, Utrecht, Netherlands; Oslo, Oslo, Norway; Stockholm, Stockholm County, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.