EUCTR2015-002185-23-IT
Active, not recruiting
Phase 1
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) - INT - DIPG 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- diffuse intrinsic pontine glioma
- Sponsor
- FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI
- Enrollment
- 79
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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)
- •\- Symptoms lasting less than 6 months
- •\- Life expectancy \=4 weeks
- •\- Karnowski/Lansky performance status \> or \= 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\-
Exclusion Criteria
- •\- 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 disfunction, pregnancy or breast\-feeding
- •\- Absence of parents, patient or tutor consent
- •\- Not central review diagnosis of diffuse midline glioma histone H3, K27 mutated
Outcomes
Primary Outcomes
Not specified
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