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Phase 2 open label randomized study of radiotherapy, concomitant nimotuzumab and vinorelbine and re-irradiation at relapse versus radiotherapy and multiple elective radiotherapy courses with concomitant vinorelbine and nimotuzumab for newly diagnosed childhood and adolescence diffuse intrinsic pontine glioma (DIPG).
EU CTIS ID: 2024-513654-30-00
What this study is testing
Primary aim of this study will be compare the best response up to 36 weeks (CR+PR) between conventional and experimental irradiation.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients from 2 to 21 years old will be eligible
- No previous treatment consented apart from steroids
- Strict eligibility criteria will radiologically-verified DIPG (an intrinsic, pontine-based infiltrative lesion hypointense on T1- and hyperintense on T2-weighted sequences, involving at least 2/3 of the pons) [Hargrave]
- Symptoms lasting less than 6 months, life expectancy ≥4 weeks; Karnowski/Lansky performance status ≥ 40 %
- No organ dysfunction; no pregnancy or breast-feeding
- Patients undergo baseline cranial MRI with gadolinium, to be repeated if treatment begins more than 2 weeks; spinal MRI due to the occurrence of metastatic cases at diagnosis will also be mandatory
You likely can't join if
- Patients below 2 years or over 21
- Pre-treatment with radio or chemotherapy
- Neurofibromatosis 1
- Non-typical imaging
- Symptoms duration over 6 months, Lansky/Karnowski scores below 40%
- Metastatic disease as shown by MRI
See the full eligibility criteria
- Patients from 2 to 21 years old will be eligible
- No previous treatment consented apart from steroids
- Strict eligibility criteria will radiologically-verified DIPG (an intrinsic, pontine-based infiltrative lesion hypointense on T1- and hyperintense on T2-weighted sequences, involving at least 2/3 of the pons) [Hargrave]
- Symptoms lasting less than 6 months, life expectancy ≥4 weeks; Karnowski/Lansky performance status ≥ 40 %
- No organ dysfunction; no pregnancy or breast-feeding
- Patients undergo baseline cranial MRI with gadolinium, to be repeated if treatment begins more than 2 weeks; spinal MRI due to the occurrence of metastatic cases at diagnosis will also be mandatory
- Written and signed informed consent from parents or legal guardians will be obtained before starting the treatment
- For diffuse midline glioma observational arm, central reviewed pathology of the disease according to standard Italian procedure, i.e. referral to the Neuropathology at Sapienza University in Rome
- Patients below 2 years or over 21
- Pre-treatment with radio or chemotherapy
- Neurofibromatosis 1
- Non-typical imaging
- Symptoms duration over 6 months, Lansky/Karnowski scores below 40%
- Metastatic disease as shown by MRI
- Organ dysfunction, pregnancy or breast-feeding
- Absence of parents, patient or tutor consent
- Not central review diagnosis of diffuse midline glioma histone H3, K27 mutated
The study team makes the final eligibility decision.
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, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.