Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085202
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2004-06-10
Brief Title:
Treatment of Patients With Newly Diagnosed Medulloblastoma Supratentorial Primitive Neuroectodermal Tumor or Atypical Teratoid Rhabdoid Tumor
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Treatment of Patients With Newly Diagnosed Medulloblastoma Supratentorial Primitive Neuroectodermal Tumor or Atypical Teratoid Rhabdoid Tumor
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 25 years after diagnosis and then every 6 months until month 72 6 years after diagnosis
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 25 years after diagnosis and then every 6 months until month 72 6 years after diagnosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-01185 | REGISTRY | NCI Clinical Trial Registration Program | None |