Stratum S-2 for Medulloblastoma
Phase-Based Progress Estimates
Effectiveness
Safety
St. Jude Children's Research Hospital, Memphis, TN
Medulloblastoma
Methotrexate - DrugEligibility
< 18
All Sexes
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Eligibility
< 18
All Sexes
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Study Summary
This is a multi-center, multinational phase 2 trial that aims to explore the use of molecular and clinical risk-directed therapy in treatment of children 0-4.99 years of age with newly diagnosed medulloblastoma.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 23 Secondary · Reporting Duration: Baseline and 6 months after enrollment
All samples acquired during each course C for domestic patients and patients at St. Jude only.
To characterize the plasma systemic clearance (CL) of topotecan (TPT) in infants and young children with medulloblastoma.
All samples acquired during each course C for domestic patients and patients at St. Jude, only.
To assess potential covariates (e.g., demographics, clinical chemistry) explaining inter- and intra-patient variability in TPT PK parameter (CL) in infants and young children with medulloblastoma receiving TPT.
Month 6
Magnitude of change in cognition and social-emotional development associated with a caregiver education program combined with interactive neurodevelopmental games.
Year 5
Association of familial factors and environmental factors with cognitive late effects.
Association of familial factors and environmental factors with socioeconomic status
Change in IQ among infants (0-2.99 years) and young children (3-4.99 years) treated for medulloblastoma
Change in executive function among infants (0-2.99 years) and young children (3-4.99 years) treated for medulloblastoma
Change in health-related quality of life among infants (0-2.99 years) and young children (3-4.99 years) treated for medulloblastoma
Executive function among infants and young children treated with systemic chemotherapy only compared to patients treated with systemic chemotherapy and intra-ventricular chemotherapy or delayed risk-adapted craniospinal irradiation
Health-related quality of life among infants and young children treated with systemic chemotherapy only compared to patients treated with systemic chemotherapy and intra-ventricular chemotherapy or delayed risk-adapted craniospinal irradiation
IQ among infants and young children treated with systemic chemotherapy only compared to patients treated with systemic chemotherapy and intra-ventricular chemotherapy or delayed risk-adapted craniospinal irradiation
Month 6
Evaluate family interest in caregiver education combined with interactive neurodevelopmental games.
Evaluate intervention feasibility by measuring the rate of participants completing a caregiver education combined with interactive. neurodevelopmental games.
Evaluate the acceptability of a caregiver education combined with interactive neurodevelopmental games.
Day 8
To assess potential covariates (e.g., demographics, clinical chemistry) explaining inter- and intra-patient variability in VCR PK parameter (CL) in infants and young children with medulloblastoma receiving VCR.
To characterize the plasma systemic clearance (CL) of vincristine (VCR) in infants and young children with medulloblastoma.
Day 9
To assess potential covariates (e.g., demographics, clinical chemistry) explaining inter- and intra-patient variability in 4OHCTX AUC0-24h in infants and young children with medulloblastoma receiving CTX.
Day 9
To assess potential covariates (e.g., demographics, clinical chemistry) explaining inter- and intra-patient variability in CEPM AUC0-24h in infants and young children with medulloblastoma receiving CTX.
Day 9
To assess potential covariates (e.g., demographics, clinical chemistry) explaining inter- and intra-patient variability in in the plasma systemic clearance (CL) of CTX in infants and young children with medulloblastoma receiving CTX.
Day 1
To assess potential covariates (e.g., demographics, clinical chemistry) explaining inter- and intra-patient variability in 7OHMTX PK parameter AUC0-24h in infants and young children with medulloblastoma receiving MTX.
To assess potential covariates (e.g., demographics, clinical chemistry) explaining inter- and intra-patient variability in MTX PK parameter CL in infants and young children with medulloblastoma receiving MTX.
To characterize the area under the concentration-time curve (AUC0-24h) of 7-hydroxymethotrexate (7OHMTX) in infants and young children with medulloblastoma receiving methotrexate.
To characterize the plasma systemic methotrexate (MTX) clearance (CL) in infants and young children with medulloblastoma.
Day 9
To characterize the area under the concentration-time curve (AUC0-24h) of 4-hydroxy-cyclophosphamide (4OHCTX) in infants and young children with medulloblastoma receiving cyclophosphamide.
To characterize the area under the concentration-time curve (AUC0-24h) of carboxyethylphosphoramide (CEPM) in infants and young children with medulloblastoma receiving cyclophosphamide.
To characterize the plasma systemic clearance (CL) of cyclophosphamide (CTX) in infants and young children with medulloblastoma.
Year 7
Progression free survival of G3/G4 infant (0-2.99 years) medulloblastoma patients treated with systemic chemotherapy and delayed risk-adapted CSI augmented with carboplatin.
Progression free survival of SHH-1 infant (0-2.99 years) medulloblastoma patients treated with systemic HD-MTX-based chemotherapy augmented with IVT-MTX.
Progression free survival of SHH-2 infant (0-2.99 years) and young child (3-4.99 years) medulloblastoma patients treated with systemic HD-MTX-based chemotherapy only.
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
3 Treatment Groups
Stratum S-2
1 of 3
Stratum S-1
1 of 3
Stratum N
1 of 3
Experimental Treatment
120 Total Participants · 3 Treatment Groups
Primary Treatment: Stratum S-2 · No Placebo Group · Phase 2
Stratum S-2Experimental Group · 9 Interventions: Methotrexate, Carboplatin, Topotecan, Cyclophosphamide, Surgical resection, Cisplatin, Vincristine, Filgrastim, Pegfilgrastim · Intervention Types: Drug, Drug, Drug, Drug, Procedure, Drug, Drug, Drug, Drug
Stratum S-1Experimental Group · 10 Interventions: Methotrexate, Carboplatin, Topotecan, Cyclophosphamide, Surgical resection, Cisplatin, Ommaya/VPS, Vincristine, Filgrastim, Pegfilgrastim · Intervention Types: Drug, Drug, Drug, Drug, Procedure, Drug, Procedure, Drug, Drug, Drug
Stratum NExperimental Group · 11 Interventions: Methotrexate, Carboplatin, Topotecan, Cyclophosphamide, Surgical resection, Cisplatin, Vincristine, Filgrastim, Etoposide, Irradiation, Pegfilgrastim · Intervention Types: Drug, Drug, Drug, Drug, Procedure, Drug, Drug, Drug, Drug, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate
2014
Completed Phase 4
~3550
Carboplatin
2014
Completed Phase 3
~6570
Topotecan
2017
Completed Phase 3
~1930
Cyclophosphamide
1995
Completed Phase 3
~4020
Surgical resection
2012
Completed Early Phase 1
~590
Cisplatin
2013
Completed Phase 3
~3340
Vincristine
2003
Completed Phase 4
~2820
Filgrastim
2000
Completed Phase 3
~3650
Etoposide
2010
Completed Phase 3
~2370
Irradiation
2015
N/A
~490
Pegfilgrastim
2006
Completed Phase 3
~4180
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 6 months after enrollment
Closest Location: St. Jude Children's Research Hospital · Memphis, TN
2011First Recorded Clinical Trial
24 TrialsResearching Medulloblastoma
339 CompletedClinical Trials
Eligibility Criteria
Age < 18 · All Participants · 6 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have adequate tumor tissue from primary tumor for central review of pathology and molecular classification by methylation and IHC.
Parent or legal guardian can understand and is willing to sign a written informed consent document according to institutional guidelines.
You have a presumptive/suspected newly diagnosed medulloblastoma.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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