Health Trials

Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation

ConditionsCNS Embryonal TumorCNS, MedulloblastomaAtypical Teratoid Rhabdoid TumorMedulloblastoma, ChildhoodMedulloblastoma, Group 3Medulloblastoma, Group 4PineoblastomaNeuroblastomaEmbryonal Tumor With Multilayered RosettesEmbryonal Tumor With Abundant Neuropil and True RosettesEpendymoblastomaMedulloepitheliomaCNS Embryonal Tumor With Rhabdoid FeaturesCNS Embryonal Tumor, Nos
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeUp to 6
SponsorC17 Council

About this trial

Pilot study to determine feasibility of adding intrathecal chemotherapy and maintenance therapy after high dose chemotherapy for treatment of newly diagnosed HR-EBTs in patients less than 6 years of age.

Eligibility criteria

Qualifiers

Tumor Tissue Sample

Age: Patient must be aged ≥ 0 years to ≤ 6 years at the time of definitive confirmation of histologic diagnosis of eligible CNS tumor.

Diagnoses. Participants must have Central nervous system (CNS) HR-EBT including atypical teratoid rhabdoid tumour (ATRT), group 3 and group 4 medulloblastoma (MB), pineoblastoma, CNS neuroblastoma, embryonal tumor with multi-layered rosettes (ETMR including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified), medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI-1 intact) and CNS embryonal tumor, not otherwise specified. Metastatic disease included. Any extent of resection included.

Cranial and Spine MRI. A baseline MRI brain and spine with and without contrast is required for all patients. cranial MRI (with and without gadolinium) must be done pre-operatively. Post-operatively, cranial MRI (with and without gadolinium) must be done.

Disqualifiers

Patients who are receiving any other conventional anti-cancer agents or investigational agents.

Patients who received previous therapy including radiotherapy or chemotherapy other than corticosteroids.

Presence of another malignancy, except if the other primary malignancy is neither currently clinically significant nor requiring active intervention.

Concomitant medications restrictions: Concurrent use of enzyme inducing anticonvulsants (e.g. phenytoin, phenobarbital, and carbamazepine), selected strong inhibitors of cytochrome P450 3A4 include azole antifungals, such as fluconazole, voriconazole, itraconazole, ketoconazole, and strong inducers include drugs such as rifampin, phenytoin, phenobarbitol, carbamazepine, and St. John's wort or CYP450 3A4 stimulators or inhibitors.

Trial design

Treatments tested in this trial

  • Cytarabine IT
  • hydrocortisone
  • Cisplatin
  • Vincristine
  • Etoposide
  • Cyclophosphamide
  • Mesna
  • Filgrastim
  • carboplatin
  • Thiotepa
  • Topotecan IT
  • Tamoxifen
  • ISOtretinoin
  • Celecoxib
  • etoposide phosphate
  • Temozolomide

Treatment groups

15 Participants
are divided into 1 treatment group

Locations

12
Alberta
Alberta Children's Hospital Calgary Canada
British Columbia
BC Children's Hospital Vancouver Canada
Manitoba
CancerCare Manitoba (CCMB) Winnipeg Canada
Nova Scotia
IWK Health Centre Halifax Canada

Sponsors and collaborators

C17 Council

Lead sponsor

Source ClinicalTrials.gov