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Clinical Trials/NL-OMON55597
NL-OMON55597RecruitingPhase 3

AN INTERNATIONAL PROSPECTIVE TRIAL ON MEDULLOBLASTOMA (MB) IN CHILDREN OLDER THAN 3 TO 5 YEARS WITH WNT BIOLOGICAL PROFILE (PNET 5 MB - LR and PNET 5 MB - WNT-HR), AVERAGE-RISK BIOLOGICAL PROFILE (PNET 5 MB -SR), OR TP53 MUTATION AND REGISTRY FOR MB OCCURRING IN THE CONTEXT OF GENETIC PREDISPOSITION - SIOP PNET 5 MB

niversity Medical Centre Hamburg-Eppendorf0 sites30 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
Enrollment
30
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
2 to 99 (—)

Inclusion Criteria

  • •GENERAL INCLUSION CRITERIA ALL STUDIES
  • •1. Submission of high quality biological material incl. fresh frozen tumour
  • •samples and blood
  • •2. CTC grades < 2 for liver, renal, haematological function
  • •3. Central pathology review, central molecular diagnosis of genetically defined
  • •subgroup, and central MRI mandatory
  • •4. Cytospin of lumbar CSF
  • •5. Written informed consent
  • •6. National and local ethical committee approval
  • •COMMON INCLUSION CRITERIA FOR LR, SR AND WNT-HR
  • •1. No prior therapy for medulloblastoma (MB) other than surgery
  • •2. Radiotherapy aiming to start no more than 28 days after surgery. Foreseeable
  • •inability to start radiotherapy within 40 days after surgery renders patients
  • •ineligible for the study. Inclusion of patients is not possible later than 40
  • •days after first tumour surgery, or after start of radiotherapy
  • •3. No significant sensineural hearing deficit
  • •4. No identified germline APC, PTCH, SUFU, TP53, PALB2, or BRCA2 gene
  • •alteration. No unrefuted clinical suspect for patient or familial
  • •APC-associated polyposis conditions, biallelic mismatch repair syndrome, Li
  • •Fraumeni Syndrome, Gorlin Snydrome, Fanconi anaemia, or other hereditary
  • •condition that affects tolerance of antitumour treatment, or may prone to
  • •secondary tumours
  • •5. No other medical contraindication to radiotherapy or chemotherapySPECIFIC
  • •INCLUSION CRITERIA LR-STUDY
  • •1. Age at diagnosis > 3-5 and < 16 years
  • •2. MB, WNT-activated; histologic subtypes: MB, classic and desmoplastic/nodular
  • •3. Clinically standard -risk MB, defined as total or near total surgical
  • •resection with less than or equal to 1.5 cm2 of residual tumour on early
  • •post-operative MRI, without and with contrast, on central review; no CNS
  • •metastasis on MRI on central review; no tumour cells on the cytospin of lumbar
  • •CSF, no clinical evidence of extra-CNS metastasis; Patients with a reduction of
  • •postoperative residual tumour through second surgery to less than or equal to
  • •1.5 cm2 are eligible, if timeline for start of radiotherapy can be kept
  • •4. No amplification of MYC or MYCN
  • •5. Low-risk biological profile, defined as presence of β-catenin mutation
  • •resulting in WNT activation
  • •SPECIFIC INCLUSION CRITERIA SR-STUDY
  • •1. Age at diagnosis >3-5 and <22 years
  • •2. MB, SHH-activated and TP53-wildtype; MB, non-WNT/non-SHH; MB, group 3; MB,
  • •group 4; Histologic subtype: MB, classic and desmoplastic/nodular
  • •3. Clinically standard-risk, defined as total or near total surgical resection
  • •with less than or equal to 1.5 cm2 of residual tumour on early post-operative
  • •MRI, without and with contrast, on central review; no CNS metastasis on MRI on
  • •central review; no tumour cells on the cytospin of lumbar CSF; no clinical
  • •evidence of extra-CNS metastasis; Patients with a reduction of postoperative
  • •residual tumour through second surgery to less than or equal to 1.5 cm2 are
  • •eligible, if timeline for start of radiotherapy can be kept
  • •4. No amplification of MYC or MYCN; MYCN amplification allowed for patients
  • •with group 4 MB
  • •5. WNT-subgroup negativity is prerequisite: WNT-negative tumours are defined by
  • +4 more not shown

Exclusion Criteria

  • •EXCLUSION CRITERIA PNET-5 MB - LR and PNET-5 MB - SR:
  • •Exclusion criteria LR
  • •1. One of the inclusion criteria is lacking;
  • •2. Brainstem or supratentorial embryonal tumour;
  • •3. Atypical teratoid rhabdoid tumour;
  • •4. Medulloepithelioma, embryonal tumour with multi-layered rosettes.
  • •5. Large cell/anaplastic medulloblastoma, or medulloblastoma with extensive
  • •nodularity (MBEN), confirmed on central pathological review.
  • •6. Unfavourable or undeterminable biological profile, defined as amplification
  • •of MYC or MYCN, or WNT subgroup status not determinable.
  • •7. Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of
  • •postoperative lumbar CSF);
  • •8. Patient previously treated for a brain tumour or any type of malignant
  • •9. identified germline APC, PTCH, SUFU, TP53, PALB2, or BRCA2 gene alteration.
  • •Unrefuted clinical suspect for patient or familial APC-associated polyposis
  • •conditions, biallelic mismatch repair syndrome, Li Fraumeni Syndrome, Gorlin
  • •Snydrome, Fanconi anaemia, or other hereditary condition that affects tolerance
  • •of antitumour treatment, or may prone to secondary tumours;
  • •10. Patients who are pregnant;
  • •11. Female patients who are sexually active and not taking reliable
  • •contraception;
  • •12. Patients who cannot be regularly followed up due to psychological, social,
  • •familial or geographic reasons;
  • •13. Patients in whom non-compliance with toxicity management guidelines can be
  • •Exclusion criteria SR
  • •1. One of the inclusion criteria is lacking;
  • •2. Brainstem or supratentorial embryonal tumour;
  • •3. Atypical teratoid rhabdoid tumour;
  • •4. Medulloepithelioma, embryonal tumour with multi-layered rosettes;
  • •5. Large-cell medulloblastoma, anaplastic medulloblastoma, or medulloblastoma
  • •with extensive nodularity (MBEN), confirmed on central pathological review;
  • •6. Unfavourable or undeterminable biological profile, defined as amplification
  • •of MYC or MYCN, or WNT subgroup status not determinable, MYCN amplification
  • •allowed for patients with group 4 medulloblastoma;
  • •7. Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of
  • •postoperative lumbar CSF);
  • •8. Patient previously treated for a brain tumour or any type of malignant
  • •9. identified germline APC, PTCH, SUFU, TP53, PALB2, or BRCA2 gene alteration.
  • •Unrefuted clinical suspect for patient or familial APC-associated polyposis
  • •conditions, biallelic mismatch repair syndrome, Li Fraumeni Syndrome, Gorlin
  • •Snydrome, Fanconi anemia, or other hereditary condition that affects tolerance
  • •of antitumour treatment, or may prone to secondary tumours
  • •10. identified somatic TP53 mutation in SHH activated tumours
  • •11. Patients who are pregnant;
  • •12. Female patients who are sexually active and not taking reliable
  • •contraception;
  • •13. Patients who cannot be regularly followed up due to psychological, social,
  • •familial or geographic reasons;
  • •14. Patients in whom non-compliance with toxicity management guidelines can be
  • •Exclusion criteria WNT-HR
  • +7 more not shown

Investigators

Sponsor
niversity Medical Centre Hamburg-Eppendorf

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