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Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor

Primary Purpose

Brain and Central Nervous System Tumors

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
filgrastim
cisplatin
cyclophosphamide
vincristine
autologous hematopoietic stem cell transplantation
radiation therapy
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring untreated childhood medulloblastoma, untreated childhood supratentorial primitive neuroectodermal tumor, childhood atypical teratoid/rhabdoid tumor, untreated childhood pineoblastoma

Eligibility Criteria

3 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of 1 of the following: Medulloblastoma Supratentorial primitive neuroectodermal tumor (PNET) PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma) Atypical teratoid rhabdoid tumor (ATRT) Definitive surgery for CNS tumor within the past 31 days Meets one of the following risk criteria: Average-risk disease Localized disease with no overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET or ATRT) by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI T4 disease eligible if all of the following are true: Gross total resection determined by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI Residual tumor or imaging abnormality whose size is < 1.5 cm^2 No evidence of CNS or extraneural metastasis by MRI of the spine (with and without contrast agent) or CT-based myelogram AND by cytologic examination of the lumbar cerebral spinal fluid (CSF) 14-28 days after surgery Brain stem invasion allowed in the absence of residual tumor (tumor < 1.5 cm^2 by imaging) High-risk disease meeting one of the following criteria: Metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination by imaging and/or cytologic examination of CSF) Presence of residual disease > 1.5 cm^2 at the primary site after surgery PATIENT CHARACTERISTICS: Age 3 to 21 at diagnosis Performance status Lansky 30-100% (< 10 years old) Karnofsky 30-100% (≥ 10 years old) (except for posterior fossa syndrome) Life expectancy Not specified Hematopoietic Hemoglobin > 8 g/dL WBC > 2,000/mm^3 Absolute neutrophil count > 500/mm^3 Platelet count > 50,000/mm^3 Hepatic ALT < 5 times normal Bilirubin < 3.0 mg/dL Renal Creatinine < 2.0 mg/dL OR Creatinine clearance > 70 mL/min Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Prior corticosteroid therapy allowed Radiotherapy No prior radiotherapy Surgery See Disease Characteristics

Sites / Locations

  • Duke Comprehensive Cancer Center
  • Children's Hospital of Philadelphia
  • St. Jude Children's Research Hospital
  • Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
  • Sydney Children's Hospital
  • Children's Hospital at Westmead
  • Lady Cilento Children's Hospital, Brisbane
  • Royal Children's Hospital
  • Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stratum 1 (high-risk group)

Stratum 2 (average-risk group)

Arm Description

Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks. Six weeks after the completion of radiotherapy, patients receive high-dose chemotherapy followed by autologous stem cell transplantation (SCT) and filgrastim (G-CSF) with post-transplantation vincristine. High-dose chemotherapy and autologous SCT repeat every 4 weeks for 3 additional courses in the absence of unacceptable toxicity. Interventions: vincristine, cisplatin, cyclophosphamide, autologous hematopoietic stem cell transplantation, filgrastim, radiation therapy

Patients undergo craniospinal radiotherapy as in stratum 1, but at a lower dose. Patients receive high-dose chemotherapy, autologous SCT, G-CSF, and post-transplantation vincristine as in stratum 1. Interventions: vincristine, cisplatin, cyclophosphamide, autologous hematopoietic stem cell transplantation, filgrastim, radiation therapy

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors
The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.
Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group.
122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.
Frequency of Mutations Associated With SHH and WNT Tumors
The frequency of mutations for the main genes associated with SHH and WNT tumors identified via targeted sequencing based on formalin fixed paraffin embedded material is provided.

Secondary Outcome Measures

Reading Decoding Composite Scores in the Intervention and Standard of Care Groups
SOC is standard-of-Care control group. Patients randomly assigned to the control group received the current standard of care. RI is Reading Intervention Group. Patients randomly assigned to Reading Intervention Group which is with The Fast ForWord program. Assessment of reading decoding was completed using the Woodcock Johnson, Third Edition (WJIII) Tests of Achievement (Woodcock, McGraw, & Mather, 2001), with particular attention given to the reading and reading-related abilities. Two subtests were completed: (1) Letter-Word Identification, and (2) Word Attack, a test requiring the patient to read phonologically regular nonwords. The combination of these two subtests provided a standardized composite score of overall reading decoding ability with a population mean of 100 and a standard deviation of 15. Scores of 90-110 are considered to be in the average range, while those 80-89 are considered low-average (refer: Journal of Pediatric Psychology 39(4) pp. 450-458, 2014).
Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa
To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation.
Associative Memory for Two Risk Group at Enrollment
Assessment of associative memory at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.
Associative Memory for Two Risk Group at 5 Years After Enrollment
Assessment of associative memory at 5 years after enrollment. Assessment of associative memory score at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.
Processing Speed for Two Risk Group at Enrollment
Assessment of Processing Speed at enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better.
Processing Speed for Two Risk Group at 5 Years After Enrollment
Assessment of Processing Speed at 5 years after enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better.
Perceptual Speed for Two Risk Group at Enrollment
Assessment of Perceptual Speed at enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better.
Perceptual Speed for Two Risk Group at 5 Years After Enrollment
Assessment of Perceptual Speed at 5 years after enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better.

Full Information

First Posted
June 10, 2004
Last Updated
October 6, 2023
Sponsor
St. Jude Children's Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00085202
Brief Title
Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
Official Title
Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2003 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. It is not yet known which radiation therapy regimen combined with chemotherapy and donor stem cell transplant is more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. This phase III trial is studying two different regimens of radiation therapy when given together with chemotherapy and autologous stem cell transplant to see how well they work in treating patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. PRIMARY OBJECTIVE: To assess the relationship between ERBB2 protein expression in tumors and progression-free survival probability for patients with medulloblastoma. To estimate the frequency of mutations associated with SHH and WNT tumors (as defined by gene expression profiling) via targeted sequencing performed in an independent cohort of WNT and SHH tumors (also defined by gene expression profiling).
Detailed Description
SECONDARY OBJECTIVES: To compare the effects of a computer-based training system specifically targeting language, reading, and learning skills (Fast ForWord, Scientific Learning Corporation) with the current standard of care on reading decoding skills as measured by individual academic testing. To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation. To correlate radiation dosimetry of target and normal tissues with rate and patterns of failure and longitudinal measures of audiometric, endocrine and cognitive effects. EXPLORATORY OBJECTIVES: To estimate the change in neuropsychological performance from the neuropsychology assessment battery (intellect, academic achievement and cognitive ability) and examine the relationship of these changes to risk group, age at diagnosis, and parent measures. To evaluate the differences between neurotoxicity in the average-risk patient group with that in the high-risk group through qMRI, and fMRI. To develop or refine novel models relating impact of medulloblastoma therapy on neurocognitive performance to quantitative and functional neuroimaging measures. OUTLINE: This is a multicenter study. Patients are stratified according to disease risk (high-risk disease vs average-risk disease). Patients in both strata undergo peripheral blood stem cell or bone marrow harvest. Stratum 1 (high-risk group): Radiotherapy: Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks. High-dose chemotherapy and autologous stem cell transplantation (SCT): Six weeks after the completion of radiotherapy, patients receive high-dose chemotherapy comprising vincristine IV followed by cisplatin IV over 6 hours on day -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo autologous SCT on day 0. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 1 and continuing until blood counts recover. Patients receive vincristine IV on day 6. High-dose chemotherapy and autologous SCT repeat every 4 weeks for 3 additional courses in the absence of unacceptable toxicity. Stratum 2 (average-risk group): Radiotherapy: Patients undergo craniospinal radiotherapy as in stratum 1, but at a lower dose. High-dose chemotherapy and autologous SCT: Patients receive high-dose chemotherapy, autologous SCT, G-CSF, and post-transplantation vincristine as in stratum 1. Some patients undergo a neuropsychology assessment at baseline, before chemotherapy, and then annually for 5 years. After completion of study therapy, patients are followed every 3 months until month 30 (2.5 years) after diagnosis and then every 6 months until month 72 (6 years) after diagnosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
untreated childhood medulloblastoma, untreated childhood supratentorial primitive neuroectodermal tumor, childhood atypical teratoid/rhabdoid tumor, untreated childhood pineoblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stratum 1 (high-risk group)
Arm Type
Experimental
Arm Description
Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks. Six weeks after the completion of radiotherapy, patients receive high-dose chemotherapy followed by autologous stem cell transplantation (SCT) and filgrastim (G-CSF) with post-transplantation vincristine. High-dose chemotherapy and autologous SCT repeat every 4 weeks for 3 additional courses in the absence of unacceptable toxicity. Interventions: vincristine, cisplatin, cyclophosphamide, autologous hematopoietic stem cell transplantation, filgrastim, radiation therapy
Arm Title
Stratum 2 (average-risk group)
Arm Type
Experimental
Arm Description
Patients undergo craniospinal radiotherapy as in stratum 1, but at a lower dose. Patients receive high-dose chemotherapy, autologous SCT, G-CSF, and post-transplantation vincristine as in stratum 1. Interventions: vincristine, cisplatin, cyclophosphamide, autologous hematopoietic stem cell transplantation, filgrastim, radiation therapy
Intervention Type
Biological
Intervention Name(s)
filgrastim
Other Intervention Name(s)
Neupogen(R), G-CSF
Intervention Description
Given subcutaneously
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
Platinol-AQ(R)
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
Cytoxan(R)
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
vincristine
Other Intervention Name(s)
Oncovin(R)
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
autologous hematopoietic stem cell transplantation
Other Intervention Name(s)
autologous HSCT
Intervention Description
Patients undergo autologous stem cell transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
RT, Craniospinal radiotherapy
Intervention Description
Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors
Description
The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.
Time Frame
2 years after tumor cell analysis in 122 participants
Title
Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group.
Description
122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.
Time Frame
2 years after tumor cell analysis in 122 participants
Title
Frequency of Mutations Associated With SHH and WNT Tumors
Description
The frequency of mutations for the main genes associated with SHH and WNT tumors identified via targeted sequencing based on formalin fixed paraffin embedded material is provided.
Time Frame
within 3.5 years following completion of accrual
Secondary Outcome Measure Information:
Title
Reading Decoding Composite Scores in the Intervention and Standard of Care Groups
Description
SOC is standard-of-Care control group. Patients randomly assigned to the control group received the current standard of care. RI is Reading Intervention Group. Patients randomly assigned to Reading Intervention Group which is with The Fast ForWord program. Assessment of reading decoding was completed using the Woodcock Johnson, Third Edition (WJIII) Tests of Achievement (Woodcock, McGraw, & Mather, 2001), with particular attention given to the reading and reading-related abilities. Two subtests were completed: (1) Letter-Word Identification, and (2) Word Attack, a test requiring the patient to read phonologically regular nonwords. The combination of these two subtests provided a standardized composite score of overall reading decoding ability with a population mean of 100 and a standard deviation of 15. Scores of 90-110 are considered to be in the average range, while those 80-89 are considered low-average (refer: Journal of Pediatric Psychology 39(4) pp. 450-458, 2014).
Time Frame
5 years postdiagnosis
Title
Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa
Description
To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation.
Time Frame
Annually for 6 years post irradiation
Title
Associative Memory for Two Risk Group at Enrollment
Description
Assessment of associative memory at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.
Time Frame
At enrollment
Title
Associative Memory for Two Risk Group at 5 Years After Enrollment
Description
Assessment of associative memory at 5 years after enrollment. Assessment of associative memory score at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.
Time Frame
At 5 years after enrollment
Title
Processing Speed for Two Risk Group at Enrollment
Description
Assessment of Processing Speed at enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better.
Time Frame
At enrollment
Title
Processing Speed for Two Risk Group at 5 Years After Enrollment
Description
Assessment of Processing Speed at 5 years after enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better.
Time Frame
At 5 years after enrollment
Title
Perceptual Speed for Two Risk Group at Enrollment
Description
Assessment of Perceptual Speed at enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better.
Time Frame
At enrollment
Title
Perceptual Speed for Two Risk Group at 5 Years After Enrollment
Description
Assessment of Perceptual Speed at 5 years after enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better.
Time Frame
At 5 years after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of 1 of the following: Medulloblastoma Supratentorial primitive neuroectodermal tumor (PNET) PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma) Atypical teratoid rhabdoid tumor (ATRT) Definitive surgery for CNS tumor within the past 31 days Meets one of the following risk criteria: Average-risk disease Localized disease with no overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET or ATRT) by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI T4 disease eligible if all of the following are true: Gross total resection determined by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI Residual tumor or imaging abnormality whose size is < 1.5 cm^2 No evidence of CNS or extraneural metastasis by MRI of the spine (with and without contrast agent) or CT-based myelogram AND by cytologic examination of the lumbar cerebral spinal fluid (CSF) 14-28 days after surgery Brain stem invasion allowed in the absence of residual tumor (tumor < 1.5 cm^2 by imaging) High-risk disease meeting one of the following criteria: Metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination by imaging and/or cytologic examination of CSF) Presence of residual disease > 1.5 cm^2 at the primary site after surgery PATIENT CHARACTERISTICS: Age 3 to 21 at diagnosis Performance status Lansky 30-100% (< 10 years old) Karnofsky 30-100% (≥ 10 years old) (except for posterior fossa syndrome) Life expectancy Not specified Hematopoietic Hemoglobin > 8 g/dL WBC > 2,000/mm^3 Absolute neutrophil count > 500/mm^3 Platelet count > 50,000/mm^3 Hepatic ALT < 5 times normal Bilirubin < 3.0 mg/dL Renal Creatinine < 2.0 mg/dL OR Creatinine clearance > 70 mL/min Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Prior corticosteroid therapy allowed Radiotherapy No prior radiotherapy Surgery See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amar Gajjar, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
Sydney Children's Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Lady Cilento Children's Hospital, Brisbane
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 0A4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
34714708
Citation
Acharya S, Guo Y, Patni T, Li Y, Wang C, Gargone M, Ashford JM, Wilson L, Faught A, Reddick WE, Patay Z, Gajjar A, Conklin HM, Merchant TE. Association Between Brain Substructure Dose and Cognitive Outcomes in Children With Medulloblastoma Treated on SJMB03: A Step Toward Substructure-Informed Planning. J Clin Oncol. 2022 Jan 1;40(1):83-95. doi: 10.1200/JCO.21.01480. Epub 2021 Oct 29.
Results Reference
derived
PubMed Identifier
33743477
Citation
Partanen M, Anghelescu DL, Hall L, Schreiber JE, Rossi M, Gajjar A, Jacola LM. Longitudinal associations between exposure to anesthesia and neurocognitive functioning in pediatric medulloblastoma. Eur J Cancer. 2021 May;148:103-111. doi: 10.1016/j.ejca.2021.02.010. Epub 2021 Mar 17.
Results Reference
derived
PubMed Identifier
33502920
Citation
Kumar R, Smith KS, Deng M, Terhune C, Robinson GW, Orr BA, Liu APY, Lin T, Billups CA, Chintagumpala M, Bowers DC, Hassall TE, Hansford JR, Khuong-Quang DA, Crawford JR, Bendel AE, Gururangan S, Schroeder K, Bouffet E, Bartels U, Fisher MJ, Cohn R, Partap S, Kellie SJ, McCowage G, Paulino AC, Rutkowski S, Fleischhack G, Dhall G, Klesse LJ, Leary S, Nazarian J, Kool M, Wesseling P, Ryzhova M, Zheludkova O, Golanov AV, McLendon RE, Packer RJ, Dunham C, Hukin J, Fouladi M, Faria CC, Pimentel J, Walter AW, Jabado N, Cho YJ, Perreault S, Croul SE, Zapotocky M, Hawkins C, Tabori U, Taylor MD, Pfister SM, Klimo P Jr, Boop FA, Ellison DW, Merchant TE, Onar-Thomas A, Korshunov A, Jones DTW, Gajjar A, Ramaswamy V, Northcott PA. Clinical Outcomes and Patient-Matched Molecular Composition of Relapsed Medulloblastoma. J Clin Oncol. 2021 Mar 1;39(7):807-821. doi: 10.1200/JCO.20.01359. Epub 2021 Jan 27.
Results Reference
derived
PubMed Identifier
33405951
Citation
Gajjar A, Robinson GW, Smith KS, Lin T, Merchant TE, Chintagumpala M, Mahajan A, Su J, Bouffet E, Bartels U, Schechter T, Hassall T, Robertson T, Nicholls W, Gururangan S, Schroeder K, Sullivan M, Wheeler G, Hansford JR, Kellie SJ, McCowage G, Cohn R, Fisher MJ, Krasin MJ, Stewart CF, Broniscer A, Buchhalter I, Tatevossian RG, Orr BA, Neale G, Klimo P Jr, Boop F, Srinivasan A, Pfister SM, Gilbertson RJ, Onar-Thomas A, Ellison DW, Northcott PA. Outcomes by Clinical and Molecular Features in Children With Medulloblastoma Treated With Risk-Adapted Therapy: Results of an International Phase III Trial (SJMB03). J Clin Oncol. 2021 Mar 1;39(7):822-835. doi: 10.1200/JCO.20.01372. Epub 2021 Jan 6.
Results Reference
derived
PubMed Identifier
25665007
Citation
Xu H, Robinson GW, Huang J, Lim JY, Zhang H, Bass JK, Broniscer A, Chintagumpala M, Bartels U, Gururangan S, Hassall T, Fisher M, Cohn R, Yamashita T, Teitz T, Zuo J, Onar-Thomas A, Gajjar A, Stewart CF, Yang JJ. Common variants in ACYP2 influence susceptibility to cisplatin-induced hearing loss. Nat Genet. 2015 Mar;47(3):263-6. doi: 10.1038/ng.3217. Epub 2015 Feb 9. Erratum In: Nat Genet. 2015 Apr;47(4):423.
Results Reference
derived
Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital
URL
http://www.stjude.org/protocols
Description
Clinical Trials Open at St. Jude

Learn more about this trial

Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor

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