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HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors

Primary Purpose

Medulloblastoma, Central Nervous System Embryonal Tumors

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Induction
Single Cycle Intensive Chemotherapy
Tandem 3 Cycle Intensive Chemotherapy
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medulloblastoma

Eligibility Criteria

undefined - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients 10 years of age at the time of definitive confirmatory eligible histologic or cytologic diagnosis of eligible CNS tumor (brain or spinal cord)
  • Patients may not have received irradiation or chemotherapy (except corticosteroids)
  • Have histologically proven diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord
  • Medulloblastoma

    • Posterior fossa classic, desmoplastic or extensive nodular or anaplastic/large cell medulloblastoma with appropriate and sufficient tumor material (FFPE or snap frozen) for proposed assays: all stages, age less than 6 years at diagnosis
    • Posterior fossa classic or anaplastic/large cell medulloblastoma with sufficient tumor material (FFPE or snap frozen) for proposed assays: clinically high-stage (neuraxis or extra-neural dissemination, M1-4), age greater than 6 years to less than 10 years at diagnosis
    • Posterior fossa medulloblastoma, those 6 years of age and above at diagnosis, will only be eligible if they have evidence of neuraxis or extraneural dissemination. Patients 6 years of age and above with low-stage (standard-risk, M0) medulloblastoma will NOT be eligible for this study, irrespective of molecular subgroup and extend of local resection
  • CNS Embryonal Tumors:

    - Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastoma, 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 (INI1 intact) and CNS embryonal tumor, not otherwise specified.

  • Must commence Induction chemotherapy within 28 days of the most recent definitive surgical procedure and within 21 days of the most recent neuro-imaging studies (MRI of brain, performed with and without gadolinium contrast, and MRI of total spine, performed with gadolinium contrast) and lumbar CSF cytological examination
  • Patients must have adequate organ functions at the time of registration:

    • Liver: bilirubin less than 1.5 mg/dL (except for patients with Gilbert's Syndrome of indirect hyperbilirubinemia) and transaminases [SGPT or ALT, and SGOT or AST] less than 2.5 (two and a half) times the upper limits of institutional normal.
    • Renal: Creatinine clearance and/or glomerular filtration rate (GFR) greater than or equal to 60 mL/min/1.73m² within 21 days of protocol therapy.
    • Bone Marrow Function:

      1. Peripheral absolute phagocyte count (APC) > 1000/ µL. APC = numbers of banded neutrophils + segmented neutrophils + metamyelocytes + monocytes + eosinophils Please note, if institution reports differential as a percentage, then APC = [percentage of banded neutrophils + segmented neutrophils+ metamyelocytes+monocytes+eosinophils] x total white cell count.
      2. Platelet Count > 100,000/µL (transfusion independent)
      3. Hemoglobin > 8 gm/dL (may have received RBC transfusions).

Exclusion Criteria:

  • Patients older than 10 years of age at time of diagnosis
  • Following diagnoses are not eligible for study enrollment: CNS atypical teratoid/rhabdoid tumor (AT/RT); all ependymomas including anaplastic ependymomas of the brain or spinal cord; all choroid plexus carcinomas; all high-grade glial and glio-neuronal tumors; all primary CNS germ cell tumors; all primary CNS sarcomas; all primary or metastatic CNS lymphomas and solid leukemic lesions (i.e., chloromas, granulocytic sarcomas).
  • Patients with unbiopsied diffuse intrinsic pontine tumors will NOT be eligible for this study.

Sites / Locations

  • Children's of AlabamaRecruiting
  • Phoenix Children's Hospital
  • Arkansas Children's HospitalRecruiting
  • Memorial Care Health ServicesRecruiting
  • Loma Linda University Medical CenterRecruiting
  • Children's Hospital Los AngelesRecruiting
  • Mattel Children's Hospital (UCLA)Recruiting
  • UCSF Oakland BenioffRecruiting
  • Children's Hospital Orange CountyRecruiting
  • Children's Hospital ColoradoRecruiting
  • Nemours Center for Cancer and Blood DisordersRecruiting
  • Children's National Medical CenterRecruiting
  • Shands Children's Hospital/ University of FLRecruiting
  • Nemours Center for Cancer and Blood DisordersRecruiting
  • Nicklaus Children's HospitalRecruiting
  • Orlando HealthRecruiting
  • John's Hopkins All Children's HospitalRecruiting
  • Children's Healthcare of AtlantaRecruiting
  • Riley Children's Hospital/University of IndianaRecruiting
  • University of Iowa Hospital and ClinicsRecruiting
  • University of Louisville School of MedicineRecruiting
  • John's Hopkins University School of MedicineRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • University of MichiganRecruiting
  • Central Michigan UniversityRecruiting
  • Helen DeVos Children's HospitalRecruiting
  • Children's Hospital of MinnesotaRecruiting
  • Masonic Children's Hospital/University of MinnesotaRecruiting
  • Mayo ClinicRecruiting
  • Washington University School of MedicineRecruiting
  • Children's Specialty Care of NevadaRecruiting
  • Joseph Sanzari Children's Hospital/ Hackensack UniversityRecruiting
  • Morristown Medical Center, Atlantic Health System
  • Northwell HealthRecruiting
  • NYU Langone Medical CenterRecruiting
  • Columbia Presbyterian Children's HospitalRecruiting
  • Memorial Sloan Kettering Cancer Center
  • Upstate Golisano Children's Hospital/ SUNY Upstate Medical UniversityRecruiting
  • New York Medical CollegeRecruiting
  • Carolina's HealthCare System/Levine Cancer InstituteRecruiting
  • Duke University Medical CenterRecruiting
  • Akron Children's Hospital
  • Rainbow Babies & Children's HospitalRecruiting
  • Cleveland Clinic
  • Nationwide Children's HospitalRecruiting
  • Dayton Children's HospitalRecruiting
  • Penn State Hershey Children's HospitalRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Medical University of South CarolinaRecruiting
  • Vanderbilt-Ingram Cancer CenterRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Primary Children's HospitalRecruiting
  • Virginia Commonwealth UniversityRecruiting
  • American Family Children's Hospital/University of WisconsinRecruiting
  • Medical College of WisconsinRecruiting
  • B.C. Children's HospitalRecruiting
  • Alberta Children's HospitalRecruiting
  • Stollery Children's HospitalRecruiting
  • Hamilton Health/McMasters Children's Hospital, Hamilton, Canada
  • The Hospital of Sick ChildrenRecruiting
  • Starship Children's HospitalRecruiting
  • Christchurch Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Induction

Single Cycle Intensive Chemotherapy

Tandem 3 Cycle Intensive Chemotherapy

Arm Description

The 5 chemotherapy drugs used in the Induction part of treatment are vincristine, cisplatin, cyclophosphamide, etoposide and high-dose methotrexate. Three medications are also given to help reduce the side effects of the chemotherapy drugs. Filgrastim will be given through a vein or through a tiny needle into the tissue just under the skin to help blood counts recover after the chemotherapy. Mesna will be given through a vein with cyclophosphamide to help prevent bleeding in the bladder. Leucovorin will be given through a vein after the methotrexate to protect the body from the side effects of the methotrexate.

The three drugs to be used in this research study are thiotepa, etoposide and carboplatin. These drugs will be given over 6 days to help kill the cancer cells. After 72 hours from getting these drugs, previously collected and frozen blood cells will be thawed and returned through the venous catheter. Carboplatin is given by vein over 4 hours. Thiotepa is given by vein over 3 hours. Etoposide is given by vein over 3 hours. The schedule for these drugs is as follows: Day -8: Carboplatin Day -7: Carboplatin Day -6: Carboplatin Day -5: Thiotepa, Etoposide Day -4: Thiotepa, Etoposide Day -3: Thiotepa, Etoposide Day -2: Rest Day -1: Rest Day 0: Re-infusion of blood cells

The 2 drugs to be used in this treatment are thiotepa and carboplatin. These drugs will be given over 2 days to help kill the cancer cells. After 72 hours from getting these drugs, previously collected and frozen blood cells will be thawed and returned through the venous catheter. Day -4: Thiotepa, Carboplatin Day -3: Thiotepa, Carboplatin Day -2: Rest Day -1: Rest Day 0: Re-infusion of blood cells. Following recovery from the first cycle of this chemotherapy, about 28 days following the Day 0 reinfusion of blood cells, the same cycle will be repeated again. A total of 3 cycles of this therapy will be administered, over the course of 12 weeks.

Outcomes

Primary Outcome Measures

Compare tandem consolidation vs. single cycle consolidation A
Dose-intensive tandem Consolidation will be compared with single cycle consolidation via randomization. The randomized consolidations will provide an event-free survival (EFS) analysis after completing "Head Start 4" Induction.
Compare tandem consolidation vs. single cycle consolidation B
Dose-intensive tandem Consolidation will be compared with single cycle consolidation via randomization. The randomized consolidations will provide an overall survival (OS) analysis after completing "Head Start 4" Induction.

Secondary Outcome Measures

Induction Cycle Reduction
Induction chemotherapy cycles will be reduced in number from five to three for molecularly high-risk medulloblastoma (non-Shh/non-Wnt) and CNS embryonal tumors who achieve a complete response (CR) after three cycles of Induction therapy results in equivalent 3-year EFS. Outcome will be analyzed irrespective of Consolidation assignment (Primary Aim) and compared to historical controls.
Uniform Treatment Regimen
Assess the rate of response of sequential dose-intensive and dose-compressed Induction chemotherapy followed by marrow-ablative chemotherapy and autologous hematopoietic progenitor cell rescue (AuHPCR) for children with medulloblastoma and other CNS embryonal tumors enrolled on the "Head Start 4" study utilizing a uniform treatment regimen.
Therapy-Related Hearing Loss Evaluation A
The prevalence and severity of therapy-related hearing loss as a function of cumulative dosing of cisplatin (three versus five cycles during Induction) will be evaluated. Distortion-Product Oto-acoustic Emissions (DPOAE) will be used as an early predictor of hearing loss to identify at-risk patients.
Therapy-Related Hearing Loss Evaluation B
The prevalence and severity of therapy-related hearing loss as a function of AuHPCR (one versus three tandem transplants in Consolidation) will be evaluated. Distortion-Product Oto-acoustic Emissions (DPOAE) will be used as an early predictor of hearing loss to identify at-risk patients.
Neuropsychological effects will be evaluated using age based tests and questionnaires.
The long-term neuropsychological effects will be evaluated.
Endocrine studies will be conducted using Serum-free T4, TSH, Cortisol, IGF and IGFBP3 laboratory tests.
The long-term endocrine functions effect will be evaluated.
Physical growth will be evaluated by collecting patient's height, weight and BSA.
The long-term physical growth effect will be evaluated.
The development of second neoplasms will be monitored.
The long-term development of second neoplasms will be evaluated.
Neuropathology Biorepository and Clinical Database
The study will establish a "Head Start 4" repository of clinical, radiographic and biologic specimens, including nucleic acids derived from these specimens, for future genomic, biologic and pharmacologic research.

Full Information

First Posted
April 27, 2016
Last Updated
June 5, 2023
Sponsor
Nationwide Children's Hospital
Collaborators
Children's of Alabama
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1. Study Identification

Unique Protocol Identification Number
NCT02875314
Brief Title
HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors
Official Title
HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
Children's of Alabama

4. Oversight

Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective randomized clinical trial, to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a superior outcome compared to the single cycle Consolidation, given the substantially higher dose intensity of the tandem regimen, without significant addition of either short-term or long-term morbidities.
Detailed Description
Due to the inferior response and event-free survival data of Regimens D and D2 on "Head Start III" for all children with supratentorial embryonal tumors, in comparison with the published data from "Head Start II" with Regimen A2 for metastatic patients, all such patients will receive the "Head Start II" Induction Regimen A2, on "Head Start 4", for either three or five cycles, depending upon whether or not they achieve complete remission by the end of Induction cycle #3. They will then undergo randomization to either single cycle or three tandem cycles of Consolidation marrow-ablative chemotherapy with AuHPCR. Because of the unsatisfactory event-free survival for young children with non-desmoplastic/extensive nodular medulloblastoma (predominantly non-Shh and non-Wnt medulloblastoma subgroups) on Regimens D and D2 of "Head Start III", all these patients will receive the "Head Start II" Induction Regimen A2 on ""Head Start 4"", for either three or five cycles, depending upon whether or not they achieve complete remission by the end of Induction cycle #3. They will then undergo randomization to either single cycle or three tandem cycles of Consolidation marrow-ablative chemotherapy with AuHPCR. Because of the excellent event-free and overall survival for young children with good risk medullo-blastoma (Shh or Wnt subgroups) treated with up-front "Head Start" chemotherapy strategies, such patients will undergo risk-tailored reduction of duration of Induction therapy from five cycles to three cycles of the "Head Start II" Induction Regimen A2 on "Head Start 4" for patients achieving a complete response to 3 cycles, followed, provided they are also without evidence of residual tumor following recovery from Induction cycle #3. They will NOT then undergo randomization, but will follow with a single cycle of Consolidation marrow-ablative chemotherapy as in "Head Start" studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medulloblastoma, Central Nervous System Embryonal Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction
Arm Type
Experimental
Arm Description
The 5 chemotherapy drugs used in the Induction part of treatment are vincristine, cisplatin, cyclophosphamide, etoposide and high-dose methotrexate. Three medications are also given to help reduce the side effects of the chemotherapy drugs. Filgrastim will be given through a vein or through a tiny needle into the tissue just under the skin to help blood counts recover after the chemotherapy. Mesna will be given through a vein with cyclophosphamide to help prevent bleeding in the bladder. Leucovorin will be given through a vein after the methotrexate to protect the body from the side effects of the methotrexate.
Arm Title
Single Cycle Intensive Chemotherapy
Arm Type
Experimental
Arm Description
The three drugs to be used in this research study are thiotepa, etoposide and carboplatin. These drugs will be given over 6 days to help kill the cancer cells. After 72 hours from getting these drugs, previously collected and frozen blood cells will be thawed and returned through the venous catheter. Carboplatin is given by vein over 4 hours. Thiotepa is given by vein over 3 hours. Etoposide is given by vein over 3 hours. The schedule for these drugs is as follows: Day -8: Carboplatin Day -7: Carboplatin Day -6: Carboplatin Day -5: Thiotepa, Etoposide Day -4: Thiotepa, Etoposide Day -3: Thiotepa, Etoposide Day -2: Rest Day -1: Rest Day 0: Re-infusion of blood cells
Arm Title
Tandem 3 Cycle Intensive Chemotherapy
Arm Type
Experimental
Arm Description
The 2 drugs to be used in this treatment are thiotepa and carboplatin. These drugs will be given over 2 days to help kill the cancer cells. After 72 hours from getting these drugs, previously collected and frozen blood cells will be thawed and returned through the venous catheter. Day -4: Thiotepa, Carboplatin Day -3: Thiotepa, Carboplatin Day -2: Rest Day -1: Rest Day 0: Re-infusion of blood cells. Following recovery from the first cycle of this chemotherapy, about 28 days following the Day 0 reinfusion of blood cells, the same cycle will be repeated again. A total of 3 cycles of this therapy will be administered, over the course of 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Induction
Other Intervention Name(s)
vincristine, cisplatin, cyclophosphamide, etoposide, high-dose methotrexate
Intervention Description
vincristine, cisplatin, cyclophosphamide, etoposide, high-dose methotrexate
Intervention Type
Drug
Intervention Name(s)
Single Cycle Intensive Chemotherapy
Other Intervention Name(s)
Carboplatin, thiotepa, etoposide
Intervention Description
Carboplatin, thiotepa, etoposide
Intervention Type
Drug
Intervention Name(s)
Tandem 3 Cycle Intensive Chemotherapy
Other Intervention Name(s)
Carboplatin, thiotepa
Intervention Description
Carboplatin, thiotepa
Primary Outcome Measure Information:
Title
Compare tandem consolidation vs. single cycle consolidation A
Description
Dose-intensive tandem Consolidation will be compared with single cycle consolidation via randomization. The randomized consolidations will provide an event-free survival (EFS) analysis after completing "Head Start 4" Induction.
Time Frame
5 years
Title
Compare tandem consolidation vs. single cycle consolidation B
Description
Dose-intensive tandem Consolidation will be compared with single cycle consolidation via randomization. The randomized consolidations will provide an overall survival (OS) analysis after completing "Head Start 4" Induction.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Induction Cycle Reduction
Description
Induction chemotherapy cycles will be reduced in number from five to three for molecularly high-risk medulloblastoma (non-Shh/non-Wnt) and CNS embryonal tumors who achieve a complete response (CR) after three cycles of Induction therapy results in equivalent 3-year EFS. Outcome will be analyzed irrespective of Consolidation assignment (Primary Aim) and compared to historical controls.
Time Frame
5 years
Title
Uniform Treatment Regimen
Description
Assess the rate of response of sequential dose-intensive and dose-compressed Induction chemotherapy followed by marrow-ablative chemotherapy and autologous hematopoietic progenitor cell rescue (AuHPCR) for children with medulloblastoma and other CNS embryonal tumors enrolled on the "Head Start 4" study utilizing a uniform treatment regimen.
Time Frame
5 years
Title
Therapy-Related Hearing Loss Evaluation A
Description
The prevalence and severity of therapy-related hearing loss as a function of cumulative dosing of cisplatin (three versus five cycles during Induction) will be evaluated. Distortion-Product Oto-acoustic Emissions (DPOAE) will be used as an early predictor of hearing loss to identify at-risk patients.
Time Frame
5 years
Title
Therapy-Related Hearing Loss Evaluation B
Description
The prevalence and severity of therapy-related hearing loss as a function of AuHPCR (one versus three tandem transplants in Consolidation) will be evaluated. Distortion-Product Oto-acoustic Emissions (DPOAE) will be used as an early predictor of hearing loss to identify at-risk patients.
Time Frame
5 years
Title
Neuropsychological effects will be evaluated using age based tests and questionnaires.
Description
The long-term neuropsychological effects will be evaluated.
Time Frame
5 years
Title
Endocrine studies will be conducted using Serum-free T4, TSH, Cortisol, IGF and IGFBP3 laboratory tests.
Description
The long-term endocrine functions effect will be evaluated.
Time Frame
5 years
Title
Physical growth will be evaluated by collecting patient's height, weight and BSA.
Description
The long-term physical growth effect will be evaluated.
Time Frame
5 years
Title
The development of second neoplasms will be monitored.
Description
The long-term development of second neoplasms will be evaluated.
Time Frame
5 years
Title
Neuropathology Biorepository and Clinical Database
Description
The study will establish a "Head Start 4" repository of clinical, radiographic and biologic specimens, including nucleic acids derived from these specimens, for future genomic, biologic and pharmacologic research.
Time Frame
5 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 10 years of age at the time of definitive confirmatory eligible histologic or cytologic diagnosis of eligible CNS tumor (brain or spinal cord) Patients may not have received irradiation or chemotherapy (except corticosteroids) Have histologically proven diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord Medulloblastoma Posterior fossa classic, desmoplastic or extensive nodular or anaplastic/large cell medulloblastoma with appropriate and sufficient tumor material (FFPE or snap frozen) for proposed assays: all stages, age less than 6 years at diagnosis Posterior fossa classic or anaplastic/large cell medulloblastoma with sufficient tumor material (FFPE or snap frozen) for proposed assays: clinically high-stage (neuraxis or extra-neural dissemination, M1-4), age greater than 6 years to less than 10 years at diagnosis Posterior fossa medulloblastoma, those 6 years of age and above at diagnosis, will only be eligible if they have evidence of neuraxis or extraneural dissemination. Patients 6 years of age and above with low-stage (standard-risk, M0) medulloblastoma will NOT be eligible for this study, irrespective of molecular subgroup and extend of local resection CNS Embryonal Tumors: - Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastoma, 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 (INI1 intact) and CNS embryonal tumor, not otherwise specified. Must commence Induction chemotherapy within 28 days of the most recent definitive surgical procedure and within 21 days of the most recent neuro-imaging studies (MRI of brain, performed with and without gadolinium contrast, and MRI of total spine, performed with gadolinium contrast) and lumbar CSF cytological examination Patients must have adequate organ functions at the time of registration: Liver: bilirubin less than 1.5 mg/dL (except for patients with Gilbert's Syndrome of indirect hyperbilirubinemia) and transaminases [SGPT or ALT, and SGOT or AST] less than 2.5 (two and a half) times the upper limits of institutional normal. Renal: Creatinine clearance and/or glomerular filtration rate (GFR) greater than or equal to 60 mL/min/1.73m² within 21 days of protocol therapy. Bone Marrow Function: Peripheral absolute phagocyte count (APC) > 1000/ µL. APC = numbers of banded neutrophils + segmented neutrophils + metamyelocytes + monocytes + eosinophils Please note, if institution reports differential as a percentage, then APC = [percentage of banded neutrophils + segmented neutrophils+ metamyelocytes+monocytes+eosinophils] x total white cell count. Platelet Count > 100,000/µL (transfusion independent) Hemoglobin > 8 gm/dL (may have received RBC transfusions). Exclusion Criteria: Patients older than 10 years of age at time of diagnosis Following diagnoses are not eligible for study enrollment: CNS atypical teratoid/rhabdoid tumor (AT/RT); all ependymomas including anaplastic ependymomas of the brain or spinal cord; all choroid plexus carcinomas; all high-grade glial and glio-neuronal tumors; all primary CNS germ cell tumors; all primary CNS sarcomas; all primary or metastatic CNS lymphomas and solid leukemic lesions (i.e., chloromas, granulocytic sarcomas). Patients with unbiopsied diffuse intrinsic pontine tumors will NOT be eligible for this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Blue, MPH
Phone
614-722-3686
Email
megan.blue@nationwidechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Melinda Triplet, RN
Phone
614-722-6039
Email
melinda.triplet@nationwidechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randal Olshefski, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Finlay, MD
Organizational Affiliation
Global Neuro-Oncology, Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Girish Dhall, MD
Organizational Affiliation
Children's of Alabama at UAB
Official's Role
Study Chair
Facility Information:
Facility Name
Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Girish Dhall, MD
Phone
205-638-9100
Email
gdhall@uabmc.edu
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Terminated
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Bielamowicz, MD
Phone
501-364-1494
Email
KJBielamowicz2@uams.edu
Facility Name
Memorial Care Health Services
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Kramer, MD
Phone
833-675-5437
Email
kramerk@MSKCC.ORG
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Kheradpour, MD
Phone
909-558-4076
Email
akheradpour@llu.edu
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom B Davidson, MD
Phone
310-825-9124
Email
tdavidson@chla.usc.edu
Facility Name
Mattel Children's Hospital (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theodore Moore, MD
Phone
310-825-0867
Email
TBMoore@mednet.ucla.edu
Facility Name
UCSF Oakland Benioff
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Hastings, MD
Phone
510-428-3631
Email
caroline.hastings@ucsf.edu
Facility Name
Children's Hospital Orange County
City
Orange
State/Province
California
ZIP/Postal Code
91868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariko Sato, MD
Phone
714-410-5947
Email
Mariko.Sato@choc.org
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Dorris, MD
Phone
720-777-8314
Email
Kathleen.Dorris@childrenscolorado.org
Facility Name
Nemours Center for Cancer and Blood Disorders
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Walter, MD
Phone
302-651-5500
Email
andrew.walter@nemours.org
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugene Hwang, MD
Phone
202-476-2800
Email
ehwang@childrensnational.org
Facility Name
Shands Children's Hospital/ University of FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sridharan Gururangan, MD
Phone
312-294-8347
Email
Sridharan.Gururangan@neurosurgery.ufl.edu
Facility Name
Nemours Center for Cancer and Blood Disorders
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J Joyce, MD, PhD
Phone
904-697-3793
Email
michael.joyce@nemours.org
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziad Khatib, MD
Phone
305-662-8360
Email
ziad.khatib@mch.com
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Smith, MD
Phone
321-841-8588
Email
Amy.Smith@orlandohealth.com
Facility Name
John's Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacie Stapleton, MD
Phone
727-767-4176
Email
stacie.stapleton@jhmi.edu
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Mazewski, MD
Phone
404-213-7777
Email
Claire.Mazewski@choa.org
Facility Name
Riley Children's Hospital/University of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Runco, MD
Phone
317-944-2143
Email
drunco@iupui.edu
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Dickens, MD
Phone
319-356-3595
Email
david-dickens@uiowa.edu
Facility Name
University of Louisville School of Medicine
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Huang, MD
Phone
502-852-8450
Email
mchuan01@exchange.louisville.edu
Facility Name
John's Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Cohen, MD
Phone
410-614-5055
Email
kcohen@jhmi.edu
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Chi, MD
Phone
617-632-4386
Email
Susan_Chi@dfci.harvard.edu
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Koschmann, MD
Phone
734-615-2736
Email
ckoschma@med.umich.edu
Facility Name
Central Michigan University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamza Gorsi, MD
Phone
831-487-5861
Email
hgorsi@wayne.edu
Facility Name
Helen DeVos Children's Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Cornelius, MD
Phone
616-267-1925
Email
albert.cornelius@spectrumhealth.org
Facility Name
Children's Hospital of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Bendel, MD
Phone
612-813-6835
Email
Anne.Bendel@childrensmn.org
Facility Name
Masonic Children's Hospital/University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Moertel, MD
Phone
614-625-3229
Email
moert001@umn.edu
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Schwartz, MD
Phone
507-284-2695
Email
Schwartz.Jonathan@mayo.edu
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Cluster, MD
Phone
314-454-6018
Email
acluster@wustl.edu
Facility Name
Children's Specialty Care of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph L Lasky III, MD
Phone
702-732-1493
Email
jlasky@cure4thekids.org
Facility Name
Joseph Sanzari Children's Hospital/ Hackensack University
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derek Hanson, MD
Phone
551-996-5437
Email
Derek.hanson@hackensackmeridian.org
Facility Name
Morristown Medical Center, Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Terminated
Facility Name
Northwell Health
City
Hempstead
State/Province
New York
ZIP/Postal Code
11549
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atlas P Mark, MD
Phone
718-470-3000
Email
Matlas@northwell.edu
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Gardner, MD
Phone
212-263-9913
Email
sharon.gardner@nyumc.org
Facility Name
Columbia Presbyterian Children's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Garvin, MD
Phone
212-305-5808
Email
jhg1@columbia.edu
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Terminated
Facility Name
Upstate Golisano Children's Hospital/ SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Comito, MD
Phone
315-464-5294
Email
comitom@upstate.edu
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Pehlivan, MD
Phone
914-594-2131
Email
kpehliva@nymc.edu
Facility Name
Carolina's HealthCare System/Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chad Jacobsen, MD
Phone
704-381-9900
Email
chad.jacobsen@carolinashealthcare.org
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ashley, MBBS, PhD
Phone
919-684-4164
Email
david.ashley@duke.edu
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Individual Site Status
Terminated
Facility Name
Rainbow Babies & Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duncan Stearns, MD
Phone
216-844-3345
Email
Duncan.Stearns@uhhospitals.org
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Terminated
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Blue, MPH, CCRP
Phone
614-722-3686
Email
megan.blue@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Parth Patel, MPH, CCRP
Phone
614-722-4319
Email
parth.patel2@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Randal Olshefski, MD
Facility Name
Dayton Children's Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel C Chow
Phone
937-641-5102
Email
chowL@childrensdayton.org
Facility Name
Penn State Hershey Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Greiner, MD
Phone
717-531-6012
Email
rgreiner1@pennstatehealth.psu.edu
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Cole, MD
Phone
267-426-2285
Email
colek@email.chop.edu
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandeepkumar Kuril, MD
Phone
843-792-2957
Email
kuril@musc.edu
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Esbenshade, MD
Phone
615-322-5000
Email
Adam.Esbenshade@vumc.org
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wafik Zaky, MD
Phone
713-745-1862
Email
wzaky@mdanderson.org
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priya Chan, MD
Phone
801-662-4799
Email
priya.chan@hsc.utah.edu
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihong Wang, MD
Phone
804-828-9605
Email
Zhihong.Wang@vcuhealth.org
Facility Name
American Family Children's Hospital/University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Puccetti, MD
Phone
608-263-6420
Email
puccetti@pediatrics.wisc.edu
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
58226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryuma Tanaka, MD
Phone
414-607-5280
Email
rtanaka@mcw.edu
Facility Name
B.C. Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvia Cheng, MD, FRCPC
Phone
604-875-2345
Ext
2406
Email
Sylvia.Cheng@cw.bc.ca
Facility Name
Alberta Children's Hospital
City
Calgary
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie Lafay-Cousin, MD
Phone
403-955-2554
Email
Lucie.Lafay-Cousin@albertahealthservices.ca
Facility Name
Stollery Children's Hospital
City
Edmonton
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bev Wilson, MD
Phone
780-407-8798
Email
bev.wilson@albertahealthservices.ca
Facility Name
Hamilton Health/McMasters Children's Hospital, Hamilton, Canada
City
Hamilton
Country
Canada
Individual Site Status
Terminated
Facility Name
The Hospital of Sick Children
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Wall, MD
Phone
416-813-7654
Ext
202349
Email
donna.wall@sickkids.ca
Facility Name
Starship Children's Hospital
City
Auckland
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Tsui, MB, ChB, FRACP
Phone
(09) 307 4949
Ext
22440
Email
KarenT@adhb.govt.nz
Facility Name
Christchurch Children's Hospital
City
Christchurch
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Dodgshun, MD
Phone
+64 33640 640
Ext
80198
Email
Andrew.dodgshun@cdhb.health.nz

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors

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