Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003211
Status:
COMPLETED
Last Update Posted:
2012-11-07
First Post:
1999-11-01
Brief Title:
Chemotherapy Radiation Therapy and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Treatment of Newly Diagnosed Medulloblastoma and Supratentorial PNET in Patients At Least 3 Years With a Phase II Topotecan Window High-Risk Patients Only Risk-Adapted Radiation Therapy and Dose-Intensive Chemotherapy With Peripheral Blood Stem Cell Support
Status:
COMPLETED
Status Verified Date:
2012-11
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy and radiation therapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy or radiation therapy and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy with topotecan cyclophosphamide cisplatin and vincristine plus radiation therapy and peripheral stem cell transplantation in treating children with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumor
PURPOSE Phase II trial to study the effectiveness of chemotherapy with topotecan cyclophosphamide cisplatin and vincristine plus radiation therapy and peripheral stem cell transplantation in treating children with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumor
Detailed Description:
OBJECTIVES
Estimate the response rate to topotecan in children with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumors who have measurable residual disease after surgery Topotecan window closed to accrual 9102001
Determine the feasibility of four courses of high-dose chemotherapy vincristine cisplatin and cyclophosphamide with peripheral blood stem cell support after craniospinal irradiation CSI in these patients
Estimate the 5-year overall survival and progression-free survival in patients treated with risk-adapted CSI and high-dose chemotherapy
Compare changes in intellectual functioning in patients treated with reduced-dose vs standard-dose CSI
Estimate the incidence of ototoxicity associated with risk-adapted CSI and posterior fossa boosts given by 3-D conformal radiotherapy technique combined with amifostine and cisplatin
OUTLINE This is a multicenter study Patients are assigned to 1 of 2 treatment groups based on risk status
Group 1 average-risk Patients receive filgrastim G-CSF subcutaneously SC or IV daily until peripheral blood stem cells PBSC are harvested PBSC are harvested when blood counts recover Patients then receive craniospinal irradiation CSI 5 days a week for 6 weeks Beginning 6 weeks after completion of CSI 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 receive amifostine IV over 1 minute a maximum of 5 minutes prior to cisplatin infusion and then 3 hours into cisplatin infusion PBSC are reinfused on day 0 Patients receive G-CSF SC beginning on day 1 and continuing for a minimum of 7 days or until blood counts recover Vincristine IV is administered on day 6 G-CSF is stopped 48 hours prior to beginning subsequent courses of chemotherapy High-dose chemotherapy repeats every 4 weeks for 4 courses
Group 2 high-risk Patients receive topotecan IV over 4 hours on days 1-5 and G-CSF SC or IV beginning 24 hours after completion of the first course of topotecan and continuing until PBSC are harvested Treatment repeats every 3 weeks for 2 courses If an adequate number of PBSC are not harvested the patient undergoes a second harvest of PBSC after the second course of topotecan Patients then receive CSI high-dose chemotherapy amifostine and PBSC support as in group 1 Topotecan window closed to accrual 9102001 Patients undergo neuropsychological testing prior to radiotherapy and chemotherapy and then at 1 2 and 5 years
Patients are followed at 1 2 4 6 9 12 15 18 and 24 months and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 12-36 patients will be accrued for this study within 5 years
Estimate the response rate to topotecan in children with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumors who have measurable residual disease after surgery Topotecan window closed to accrual 9102001
Determine the feasibility of four courses of high-dose chemotherapy vincristine cisplatin and cyclophosphamide with peripheral blood stem cell support after craniospinal irradiation CSI in these patients
Estimate the 5-year overall survival and progression-free survival in patients treated with risk-adapted CSI and high-dose chemotherapy
Compare changes in intellectual functioning in patients treated with reduced-dose vs standard-dose CSI
Estimate the incidence of ototoxicity associated with risk-adapted CSI and posterior fossa boosts given by 3-D conformal radiotherapy technique combined with amifostine and cisplatin
OUTLINE This is a multicenter study Patients are assigned to 1 of 2 treatment groups based on risk status
Group 1 average-risk Patients receive filgrastim G-CSF subcutaneously SC or IV daily until peripheral blood stem cells PBSC are harvested PBSC are harvested when blood counts recover Patients then receive craniospinal irradiation CSI 5 days a week for 6 weeks Beginning 6 weeks after completion of CSI 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 receive amifostine IV over 1 minute a maximum of 5 minutes prior to cisplatin infusion and then 3 hours into cisplatin infusion PBSC are reinfused on day 0 Patients receive G-CSF SC beginning on day 1 and continuing for a minimum of 7 days or until blood counts recover Vincristine IV is administered on day 6 G-CSF is stopped 48 hours prior to beginning subsequent courses of chemotherapy High-dose chemotherapy repeats every 4 weeks for 4 courses
Group 2 high-risk Patients receive topotecan IV over 4 hours on days 1-5 and G-CSF SC or IV beginning 24 hours after completion of the first course of topotecan and continuing until PBSC are harvested Treatment repeats every 3 weeks for 2 courses If an adequate number of PBSC are not harvested the patient undergoes a second harvest of PBSC after the second course of topotecan Patients then receive CSI high-dose chemotherapy amifostine and PBSC support as in group 1 Topotecan window closed to accrual 9102001 Patients undergo neuropsychological testing prior to radiotherapy and chemotherapy and then at 1 2 and 5 years
Patients are followed at 1 2 4 6 9 12 15 18 and 24 months and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 12-36 patients will be accrued for this study within 5 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 |
|---|---|---|---|
| NCI-G98-1387 | OTHER | National Cancer Institute | None |
| SJCRH-MB-96 | OTHER | None | None |
| SJMB-96 | OTHER | None | None |