Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006258
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2000-09-11
Brief Title:
Combination Chemotherapy Followed by Radiation Therapy in Treating Patients With Medulloblastoma Supratentorial Primitive Neuroectodermal Tumor or Ependymoma
Sponsor:
Childrens Hospital Los Angeles
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Dose Intensive Chemotherapy for Patients Greater Than or Equal To 10 Years of Age With Newly Diagnosed High Stage Medulloblastoma Supratentorial Primitive Neuroectodermal Tumors PNET and Ependymoma A Feasibility Study of an Intensive Induction Chemotherapy Regimen Followed by Standard Irradiation
Status:
COMPLETED
Status Verified Date:
2004-12
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients who have surgically resected newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumor or incompletely resected ependymoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients who have surgically resected newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumor or incompletely resected ependymoma
Detailed Description:
OBJECTIVES
Determine the toxicity of adjuvant dose-intensive induction chemotherapy with cisplatin vincristine cyclophosphamide and etoposide with or without methotrexate followed by standard radiotherapy in patients with surgically resected newly diagnosed high stage medulloblastoma or supratentorial primitive neuroectodermal tumor or incompletely resected ependymoma
Determine the response rate time to progression overall survival and pattern of failure in these patients treated with this regimen
OUTLINE Patients receive dose-intensive induction chemotherapy consisting of cisplatin IV over 6 hours on day 0 vincristine IV on days 0 7 and 14 and etoposide and cyclophosphamide IV over 1 hour on days 1 and 2 Patients with M1 disease ie evidence of dissemination beyond primary tumor site also receive methotrexate IV over 4 hours on day 3 Patients receive filgrastim G-CSF subcutaneously daily beginning on day 7 and continuing until blood counts recover Chemotherapy continues every 21-28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity Patients then undergo radiotherapy 5 days a week for 65 weeks beginning 3-6 weeks after completion of chemotherapy
Patients are followed at 6 weeks then every 3 months for 2 years every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 6-20 patients will be accrued for this study
Determine the toxicity of adjuvant dose-intensive induction chemotherapy with cisplatin vincristine cyclophosphamide and etoposide with or without methotrexate followed by standard radiotherapy in patients with surgically resected newly diagnosed high stage medulloblastoma or supratentorial primitive neuroectodermal tumor or incompletely resected ependymoma
Determine the response rate time to progression overall survival and pattern of failure in these patients treated with this regimen
OUTLINE Patients receive dose-intensive induction chemotherapy consisting of cisplatin IV over 6 hours on day 0 vincristine IV on days 0 7 and 14 and etoposide and cyclophosphamide IV over 1 hour on days 1 and 2 Patients with M1 disease ie evidence of dissemination beyond primary tumor site also receive methotrexate IV over 4 hours on day 3 Patients receive filgrastim G-CSF subcutaneously daily beginning on day 7 and continuing until blood counts recover Chemotherapy continues every 21-28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity Patients then undergo radiotherapy 5 days a week for 65 weeks beginning 3-6 weeks after completion of chemotherapy
Patients are followed at 6 weeks then every 3 months for 2 years every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 6-20 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068192 | REGISTRY | None | None |
| NYU-0027H | None | None | None |
| NCI-G00-1852 | Registry Identifier | PDQ Physician Data Query | None |