Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031590
Status:
TERMINATED
Last Update Posted:
2019-04-25
First Post:
2002-03-08
Brief Title:
Low-Dose Radiation and Combination Chemotherapy Following Surgery in Children With Newly Diagnosed Medulloblastoma
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Study Of Reduced Dose Craniospinal Radiotherapy 1800 cGy And Chemotherapy In Children With Newly-Diagnosed Standard-Risk Posterior Fossa Primitive Neuro-ectodermal Tumor PNETMedulloblastoma
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated prematurely due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells but also damages normal cells in the developing brains of children Combining low-dose radiation therapy in combination with chemotherapy should be effective in treating medulloblastoma while avoiding the long-term side effects of giving higher dose radiation to children with newly diagnosed average risk medulloblastoma
Detailed Description:
OBJECTIVES
By giving reduced dose craniospinal radiation followed by nine cycles of maintenance chemotherapy comprised of alternating cycles of lomustine cisplatin and vincristine alternating with cyclophosphamide and etoposide we will reduce the late effects of higher dose radiation in children while maintaining the therapeutic efficacy 86 3-year relapse-free survival of current standard therapy
To evaluate the late neurotoxic effects of low-dose craniospinal radiotherapy in terms of cognitive endocrinologic and auditory function in these patients
OUTLINE This is a multi center study of reduced dose craniospinal radiotherapy and chemotherapy in patients ages 3 - 30 years with newly diagnosed average risk medulloblastoma
Induction chemoradiotherapy Beginning within 28 days after complete surgical resection patients undergo radiotherapy to the craniospinal axis 1800 centigray cGy followed by conformal radiotherapy to the tumor bed 5400 cGy Patients receive vincristine weekly for 6 weeks
Maintenance chemotherapy Beginning 4 weeks after the completion of craniospinal radiation therapy patients receive two 6-week courses of regimen A as outlined below alternating with one 6-week course of regimen B for a total of 9 courses AABAABAAB
Regimen A Patients receive oral lomustine and cisplatin on day 0 and vincristine on days 0 7 and 14
Regimen B Patients receive cyclophosphamide on days 0 and 1 and etoposide intravenous IV on days 0 and 1 followed by oral etoposide on days 14-34
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter with surveillance neuroimaging using Magnetic Resonance Imaging Scan MRI scan and clinical examination
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 3 years
By giving reduced dose craniospinal radiation followed by nine cycles of maintenance chemotherapy comprised of alternating cycles of lomustine cisplatin and vincristine alternating with cyclophosphamide and etoposide we will reduce the late effects of higher dose radiation in children while maintaining the therapeutic efficacy 86 3-year relapse-free survival of current standard therapy
To evaluate the late neurotoxic effects of low-dose craniospinal radiotherapy in terms of cognitive endocrinologic and auditory function in these patients
OUTLINE This is a multi center study of reduced dose craniospinal radiotherapy and chemotherapy in patients ages 3 - 30 years with newly diagnosed average risk medulloblastoma
Induction chemoradiotherapy Beginning within 28 days after complete surgical resection patients undergo radiotherapy to the craniospinal axis 1800 centigray cGy followed by conformal radiotherapy to the tumor bed 5400 cGy Patients receive vincristine weekly for 6 weeks
Maintenance chemotherapy Beginning 4 weeks after the completion of craniospinal radiation therapy patients receive two 6-week courses of regimen A as outlined below alternating with one 6-week course of regimen B for a total of 9 courses AABAABAAB
Regimen A Patients receive oral lomustine and cisplatin on day 0 and vincristine on days 0 7 and 14
Regimen B Patients receive cyclophosphamide on days 0 and 1 and etoposide intravenous IV on days 0 and 1 followed by oral etoposide on days 14-34
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter with surveillance neuroimaging using Magnetic Resonance Imaging Scan MRI scan and clinical examination
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| CHP-693 | OTHER | Childrens Hospital of Philadelphia | None |