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Clinical Trials/EUCTR2014-001929-32-SE
EUCTR2014-001929-32-SEActive, not recruitingPhase 1

Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication - BIOMEDE

Gustave Roussy0 sites368 target enrollmentStarted: June 22, 2016Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
368
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Inclusion criteria for the inclusion (registration) in BIOMEDE 2.0 study:
  • •- Diagnosis Criteria:
  • •o Diagnosis of DIPG (clinical and radiological). As biopsy is not standard
  • •for these tumors, an informed consent is required for the necessary
  • •histological verification. [Biopsy-part of BIOMEDE 2.0 trial]
  • •or o Histological diagnosis of DIPG (i.e. H3K28M or EZHIP positive Diffuse
  • •Midline Glioma located in the pons) in case the biopsy was performed
  • •before study entry. The diagnosis will be defined by 1/ diffuse glioma, 2/
  • •H3K28M mutation or loss of H3K28 trimethylation together with EZHIP
  • •overexpression. In this situation, patient will sign the consent after the
  • •diagnosis to allow central review and biomarkers assessment thereafter.
  • •o Non-brainstem diffuse midline gliomas (ND-DMG), H3K28M mutant or
  • •EZHIP-positive , will be eligible for the trial after biopsy or surgery. As
  • •biopsy and surgery is considered as standard practice for these
  • •locations, informed consent for the biopsy will not be necessary. Patient
  • •will sign the consent after the diagnosis to allow central review and
  • •biomarkers assessment thereafter.
  • •oNon-DIPG diffuse midline gliomas (ND-DMG) will be eligible for the trial
  • •before the biopsy in case the diagnosis is clinically or radiologically
  • •suspected. (..), these patients will be eligible for the treatment part of
  • •- Eligible for a biopsy, or biopsy material available for the biomarker
  • •assessment.
  • •- Age > 6 months, with no upper age limit. Children between 6 months
  • •and 3 years will be discussed on a case by case basis for inclusion in the
  • •study for the feasibility of the stereotactic biopsy.
  • •- Eligible for cerebral or craniospinal radiotherapy.
  • •- Tumor at diagnosis: no prior chemotherapy for the present cancer; no
  • •prior cerebral radiation therapy even for another neoplasm. Surgery is
  • •allowed when performed for diagnostic or therapeutic purpose.
  • •- Metastatic diseases or spinal tumors allowed; in this case, patients
  • •would receive craniospinal or spinal radiotherapy and medical treatment
  • •(everolimus or ONC201) will be postponed and only started after the end
  • •of radiotherapy.
  • •- Patients must be affiliated to a social security system or beneficiary of
  • •the same according to local requirements.
  • •- Written informed consent from parents/legal representative, patient,
  • •and age-appropriate assent before any study-specific procedures are
  • •conducted according to local, regional or national guidelines.
  • •Inclusion criteria for the randomization in BIOMEDE 2.0 study:
  • •- Patient enrolled in the BIOMEDE 2.0 study.
  • •- Life expectancy > 12 weeks after the start of study treatment.
  • •- Histological diagnosis of DIPG (as per the WHO criteria) confirmed by
  • •central pathology review, with:
  • •Typical radiology of a DIPG (mandatory central radiological review) as
  • •well as the short clinical history (less than three months of pre-existing
  • •symptoms) in case of suspected DIPG but no histological confirmation
  • •(biopsy not informative),
  • •Histological diagnosis of ND-DMG confirmed by central pathology review
  • •o mutation in the histone H3.1, H3.2, H3.3 genes
  • •o loss of H3K28me3 and EZHIP overexpression by
  • +7 more not shown

Exclusion Criteria

  • •Exclusion criteria for the inclusion (registration) in BIOMEDE 2.0 study:
  • •- Uncontrolled Spontaneous massive intratumor bleeding. Patients with
  • •post-operative bleeding will be allowed to enter the study provided the
  • •hemorrhage is controled. Same rule applies for the other post-operative
  • •complications (infection, CSF leakage, absence of wound closure,
  • •subdural collection…).
  • •- Any other concomitant anti-cancer treatment not foreseen by this
  • •protocol is not allowed, except corticosteroids and Bevacizumab which
  • •are allowed during the protocol. Bevacizumab is not allowed before and
  • •until 15 days after the surgery. The use of bevacizumab and
  • •corticosteroids will be taken into account when judging the possibility of
  • •progression/pseudoprogression.
  • •- Any other cancer diagnosed during the last 5 years.
  • •- Uncontrolled intercurrent illness or active infection.
  • •- Any other co-morbid condition that in the investigator's opinion would
  • •impair study participation.
  • •- Unable for medical follow-up (geographic, social or mental reasons).
  • •- Patient previously treated with irradiation on the brainstem for another
  • •- Participation in another clinical study with an investigational product
  • •while on study treatment.
  • •- Patient under guardianship or deprived of his/her liberty by a judicial
  • •or administrative decision or incapable of giving his/her consent.
  • •Exclusion criteria for the randomization in BIOMEDE 2.0 study:
  • •- Current organ toxicity > grade 2 according to the NCI-CTCAE version
  • •5.0 (see Appendix 2) especially cardiovascular or renal disease
  • •(including but not limited to: congenital long QT syndrome, nephrotic
  • •syndrome, glomerulopathy, uncontrolled high blood pressure despite
  • •adequate treatment).
  • •- ONC201 administration should be avoided for patients with:
  • •o Prolongation of QT/QTcF interval (QTc interval > 480 milliseconds)
  • •preferably using Frederica's QT correction formula on two ECGs
  • •separated by at least 48 hours.
  • •o A history of Torsades de pointes or heart failure, hypokalemia, or
  • •family history of prolonged QT Syndrome.
  • •o Required concomitant use of medication(s) known to prolong the
  • •QT/QTc interval. In this case, patients will be treated in the Everolimus
  • •arm without randomization (except if contra-indication to Everolimus).
  • •- Pregnant or breastfeeding women.
  • •- Patients with chronic HBV disease compatible with the trial are not
  • •excluded from the study. These patients randomized to everolimus
  • •treatment will have regular viral load monitoring throughout the study.
  • •- Patients taking strong P450 inhibitors or inducers or PgP inhibitors are
  • •not excluded from the study but drug concentration of everolimus should
  • •be monitored carefully to avoid toxicity. Preferably alternative
  • •medications should be considered. See Appendix 4 for a list of CYP3A4
  • •inducers and inhibitors.
  • •- Patient with known congenital galactose intolerance, Lapp lactase
  • •deficiency or glucose-galactose malabsorption will not be randomized
  • •and will be treated in the ONC201 arm (except if contra-indication to
  • •- Patients with known hypersensitivity to any component of Everolimus
  • +5 more not shown

Investigators

Sponsor
Gustave Roussy

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