Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003309
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With Poor Risk Medulloblastoma PNET and Disseminated Ependymoma
Status:
COMPLETED
Status Verified Date:
2023-06
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 and 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 adult patients with brain cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating adult patients with brain cancer
Detailed Description:
OBJECTIVES
Determine the complete and partial response rate of patients with adult medulloblastoma primitive neuroectodermal tumor or disseminated ependymoma treated with preradiation combination chemotherapy
Determine the progression free survival and overall survival of these adult patients treated with combination chemotherapy followed by craniospinal radiation
Determine the toxic effects associated with this treatment in these patients
OUTLINE Patients receive cisplatin IV over 6 hours etoposide IV and vincristine IV over 1-2 minutes on day 1 etoposide IV and cyclophosphamide IV over 1-2 hours on days 2-3 filgrastim G-CSF subcutaneously SC on days 4-13 and vincristine IV over 1-2 minutes on day 15 Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Within 4-6 weeks after the last chemotherapy course patients undergo radiotherapy 5 days a week for 6 to 7 weeks
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5-10 years
PROJECTED ACCRUAL A total of 33 patients will be accrued for this study within 3 years
Determine the complete and partial response rate of patients with adult medulloblastoma primitive neuroectodermal tumor or disseminated ependymoma treated with preradiation combination chemotherapy
Determine the progression free survival and overall survival of these adult patients treated with combination chemotherapy followed by craniospinal radiation
Determine the toxic effects associated with this treatment in these patients
OUTLINE Patients receive cisplatin IV over 6 hours etoposide IV and vincristine IV over 1-2 minutes on day 1 etoposide IV and cyclophosphamide IV over 1-2 hours on days 2-3 filgrastim G-CSF subcutaneously SC on days 4-13 and vincristine IV over 1-2 minutes on day 15 Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Within 4-6 weeks after the last chemotherapy course patients undergo radiotherapy 5 days a week for 6 to 7 weeks
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5-10 years
PROJECTED ACCRUAL A total of 33 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 |
|---|---|---|---|
| E4397 | None | None | None |
| SWOG-E4397 | None | None | None |