Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082797
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2004-05-14
Brief Title:
High-Dose Methotrexate and Leucovorin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Study Of Systemic High-Dose Methotrexate For The Treatment Of Glioblastoma Multiforme In Newly Diagnosed Patients With Measurable Disease
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 such as methotrexate work in different ways to stop tumor cells from dividing so they stop growing or die Leucovorin may decrease side effects caused by high-dose methotrexate
PURPOSE This phase II trial is studying how well giving high-dose methotrexate together with leucovorin works in treating patients with newly diagnosed glioblastoma multiforme
PURPOSE This phase II trial is studying how well giving high-dose methotrexate together with leucovorin works in treating patients with newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES
Primary
Determine the response in patients with newly diagnosed glioblastoma multiforme treated with high-dose methotrexate and leucovorin calcium
Secondary
Determine the acute toxicity of this regimen in these patients
Determine the duration of survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive high-dose methotrexate IV over 4 hours on day 1 and oral or IV leucovorin calcium every 6 hours beginning on day 2 and continuing until blood methotrexate levels are acceptable Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients then receive standard radiotherapy with or without chemotherapy Patients with disease progression proceed to standard radiotherapy with or without chemotherapy upon stopping methotrexate therapy
Patients are followed at 30 days and then every 2 months for up to 2 years
PROJECTED ACCRUAL A total of 19-36 patients will be accrued for this study
Primary
Determine the response in patients with newly diagnosed glioblastoma multiforme treated with high-dose methotrexate and leucovorin calcium
Secondary
Determine the acute toxicity of this regimen in these patients
Determine the duration of survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive high-dose methotrexate IV over 4 hours on day 1 and oral or IV leucovorin calcium every 6 hours beginning on day 2 and continuing until blood methotrexate levels are acceptable Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients then receive standard radiotherapy with or without chemotherapy Patients with disease progression proceed to standard radiotherapy with or without chemotherapy upon stopping methotrexate therapy
Patients are followed at 30 days and then every 2 months for up to 2 years
PROJECTED ACCRUAL A total of 19-36 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 |
|---|---|---|---|
| E1F02 | None | None | None |