Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003846
Status:
COMPLETED
Last Update Posted:
2014-07-28
First Post:
1999-11-01
Brief Title:
Radiation Therapy Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Primitive Neuroectodermal Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Treatment of High Risk Central Nervous System Embryonal Tumors With Conventional Radiotherapy and Intensive Consolidation Chemotherapy With Peripheral Blood Progenitor Cell PBSC Support
Status:
COMPLETED
Status Verified Date:
2014-07
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 Radiation therapy uses x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Peripheral stem cell transplantation may allow doctors to give higher doses of radiation therapy and chemotherapy and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of radiation therapy chemotherapy and peripheral stem cell transplantation in treating patients with primitive neuroectodermal tumors
PURPOSE Phase II trial to study the effectiveness of radiation therapy chemotherapy and peripheral stem cell transplantation in treating patients with primitive neuroectodermal tumors
Detailed Description:
OBJECTIVES
Determine the safety of postradiotherapy high-dose consolidation chemotherapy with peripheral blood stem cell PBSC support in patients with high-risk primitive neuroectodermal tumors
Determine the safety of delaying radiotherapy by approximately one month in these patients
Determine the maximum tolerated dose of thiotepa in these patients
Determine the toxic effects of intensive chemotherapy with PBSC support in these patients
Assess the time to hematopoietic recovery after PBSC infusion when intensive chemotherapy is used after craniospinal radiotherapy in these patients
Determine the overall and event-free survival of patients treated with this regimen
OUTLINE This is a dose-escalation study of thiotepa during consolidation therapy
Induction Within 31 days of initial surgery patients receive induction therapy comprising vincristine IV on day 0 cyclophosphamide IV over 2 hours on days 0 and 1 and filgrastim G-CSF subcutaneously SC beginning on day 2 and continuing for at least 7-10 days Peripheral blood stem cells PBSC are then collected
Chemoradiotherapy After blood cell counts recover and within 28 days of starting induction patients begin chemoradiotherapy Patients receive vincristine IV once weekly for 8 doses Radiotherapy is administered 5 days a week for 6 weeks beginning within the same week as the start of vincristine
Consolidation Therapy begins 4-6 weeks after the last radiation treatment in the absence of disease progression The first and third course are the same and comprise vincristine IV on day 0 carboplatin IV over 1 hour on days 0 and 1 thiotepa IV over 3 hours on days 2-4 and G-CSF SC daily beginning on day 7 PBSC are reinfused on day 7 The second course comprises vincristine IV on day 0 carboplatin IV over 1 hour on days 0 and 1 cyclophosphamide IV over 2 hours on days 2 and 3 and G-CSF SC daily beginning on day 5 PBSC are reinfused on day 5 Each course lasts 21 days
For consolidation therapy cohorts of 6-12 patients each receive escalating doses of thiotepa until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 2 of 12 patients experience dose-limiting toxicity
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 24-56 patients will be accrued for this study
Determine the safety of postradiotherapy high-dose consolidation chemotherapy with peripheral blood stem cell PBSC support in patients with high-risk primitive neuroectodermal tumors
Determine the safety of delaying radiotherapy by approximately one month in these patients
Determine the maximum tolerated dose of thiotepa in these patients
Determine the toxic effects of intensive chemotherapy with PBSC support in these patients
Assess the time to hematopoietic recovery after PBSC infusion when intensive chemotherapy is used after craniospinal radiotherapy in these patients
Determine the overall and event-free survival of patients treated with this regimen
OUTLINE This is a dose-escalation study of thiotepa during consolidation therapy
Induction Within 31 days of initial surgery patients receive induction therapy comprising vincristine IV on day 0 cyclophosphamide IV over 2 hours on days 0 and 1 and filgrastim G-CSF subcutaneously SC beginning on day 2 and continuing for at least 7-10 days Peripheral blood stem cells PBSC are then collected
Chemoradiotherapy After blood cell counts recover and within 28 days of starting induction patients begin chemoradiotherapy Patients receive vincristine IV once weekly for 8 doses Radiotherapy is administered 5 days a week for 6 weeks beginning within the same week as the start of vincristine
Consolidation Therapy begins 4-6 weeks after the last radiation treatment in the absence of disease progression The first and third course are the same and comprise vincristine IV on day 0 carboplatin IV over 1 hour on days 0 and 1 thiotepa IV over 3 hours on days 2-4 and G-CSF SC daily beginning on day 7 PBSC are reinfused on day 7 The second course comprises vincristine IV on day 0 carboplatin IV over 1 hour on days 0 and 1 cyclophosphamide IV over 2 hours on days 2 and 3 and G-CSF SC daily beginning on day 5 PBSC are reinfused on day 5 Each course lasts 21 days
For consolidation therapy cohorts of 6-12 patients each receive escalating doses of thiotepa until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 2 of 12 patients experience dose-limiting toxicity
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 24-56 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000067006 | OTHER | Clinical Trialsgov | None |
| COG-99702 | OTHER | None | None |
| CCG-99702 | OTHER | None | None |