The study is designed for patients diagnosed with a brain tumor (diffuse intrinsic pontine glioma) aged from 2 to 21 years old.

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10006143Term: Brain stem gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); diffuse intrinsic pontine glioma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002185-23-IT
• Lead Sponsor: FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 79

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-
- 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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified