Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045539
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2002-09-06
Brief Title:
Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
Sponsor:
New Approaches to Brain Tumor Therapy Consortium
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Methotrexate and Thiotepa Chemotherapy for Patients With Newly Diagnosed Primary CNS Lymphoma
Status:
COMPLETED
Status Verified Date:
2005-12
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 such as methotrexate and thiotepa work in different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining methotrexate with thiotepa in treating patients who have newly-diagnosed primary CNS lymphoma
PURPOSE Phase II trial to study the effectiveness of combining methotrexate with thiotepa in treating patients who have newly-diagnosed primary CNS lymphoma
Detailed Description:
OBJECTIVES
Determine the complete radiographic response in patients with newly diagnosed primary CNS lymphoma treated with methotrexate and thiotepa
Determine the duration of progression-free survival and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine whether tumor expression of BCL-6 is associated with response to this chemotherapy regimen and survival of these patients
Describe the relationship between initial response to steroids if administered response to this chemotherapy regimen and survival of these patients
OUTLINE This is a multicenter study
Patients receive thiotepa IV over 15 minutes on day 1 Patients also receive methotrexate IV over 4 hours on days 1 8 hours after thiotepa and 14 Beginning 24 hours after the start of methotrexate infusion patients receive leucovorin calcium IV or orally every 6 hours until rescue is achieved Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients achieving disappearance of enhancement of disease on MRI receive an additional 28-day course followed by maintenance therapy comprising thiotepa and methotrexate once a month for 11 courses
Patients undergo neuro-ophthalmologic exams annually for 2 years
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 23-39 patients will be accrued for this study within 8-20 months
Determine the complete radiographic response in patients with newly diagnosed primary CNS lymphoma treated with methotrexate and thiotepa
Determine the duration of progression-free survival and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine whether tumor expression of BCL-6 is associated with response to this chemotherapy regimen and survival of these patients
Describe the relationship between initial response to steroids if administered response to this chemotherapy regimen and survival of these patients
OUTLINE This is a multicenter study
Patients receive thiotepa IV over 15 minutes on day 1 Patients also receive methotrexate IV over 4 hours on days 1 8 hours after thiotepa and 14 Beginning 24 hours after the start of methotrexate infusion patients receive leucovorin calcium IV or orally every 6 hours until rescue is achieved Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients achieving disappearance of enhancement of disease on MRI receive an additional 28-day course followed by maintenance therapy comprising thiotepa and methotrexate once a month for 11 courses
Patients undergo neuro-ophthalmologic exams annually for 2 years
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 23-39 patients will be accrued for this study within 8-20 months
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 |
|---|---|---|---|
| JHOC-NABTT-2109 | None | None | None |
| NABTT-2109 | None | None | None |