Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098774
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2004-12-08
Brief Title:
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Intensive Chemotherapy And Immunotherapy In Patients With Newly Diagnosed Primary CNS Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-07
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 Drugs used in chemotherapy work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Giving rituximab with combination chemotherapy may kill more cancer cells
PURPOSE This phase II trial is studying how well rituximab given with combination chemotherapy works in treating patients with newly diagnosed primary CNS lymphoma
PURPOSE This phase II trial is studying how well rituximab given with combination chemotherapy works in treating patients with newly diagnosed primary CNS lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the complete response rate after remission induction therapy with the combination of high-dose methotrexate HDMTX temozolomide and rituximab at 4 months
Secondary
Determine the safety and feasibility of consolidation therapy comprising cytarabine and etoposide administered after induction therapy in these patients
Determine the percentage of patients who achieve durable complete and partial remission when treated with this regimen
Determine relapse-free survival after complete response in patients treated with this regimen
Correlate molecular markers with outcome in patients treated with this regimen
Determine the effects of this regimen on neurological function in these patients
OUTLINE This is a multicenter study
Induction Chemotherapy All induction therapy courses repeat every 28 days
Courses 1-3 Patients receive high-dose methotrexate IV over 4 hours on days 1 and 15 leucovorin calcium IV or orally every 6 hours beginning on days 2 and 16 and continuing until blood levels of methotrexate are in a safe range and oral temozolomide on days 7-11 Patients also receive rituximab IV on days 3 10 17 and 24 of course 1 and days 3 and 10 of course 2 total of 6 doses
NOTE Patients diagnosed with T-cell primary CNS lymphoma do not receive rituximab
Course 4 Patients receive oral temozolomide on days 7-11 high-dose methotrexate IV over 4 hours on day 15 and leucovorin calcium IV or orally every 6 hours beginning on day 16 and continuing until blood levels of methotrexate are in a safe range Patients achieving a complete response or a complete response unconfirmed proceed to consolidation therapy
Consolidation therapy I course 5 Beginning 4 weeks after the start of course 4 patients receive high-dose methotrexate IV over 4 hours on day 1 leucovorin calcium IV or orally every 6 hours beginning on day 2 and continuing until blood levels of methotrexate are in a safe range and oral temozolomide on days 7-11
Consolidation therapy II course 6 Beginning 3-5 weeks after the start of course 5 patients receive cytarabine IV over 2 hours twice daily and etoposide IV over 12 hours twice daily on days 1-4 and filgrastim G-CSF or sargramostim GM-CSF subcutaneously beginning on day 14 and continuing until blood counts recover
Treatment continues in the absence of disease progression
After completion of study treatment patients are followed periodically for 3 years
PROJECTED ACCRUAL A total of 27-45 patients will be accrued for this study within 2-3 years
Primary
Determine the complete response rate after remission induction therapy with the combination of high-dose methotrexate HDMTX temozolomide and rituximab at 4 months
Secondary
Determine the safety and feasibility of consolidation therapy comprising cytarabine and etoposide administered after induction therapy in these patients
Determine the percentage of patients who achieve durable complete and partial remission when treated with this regimen
Determine relapse-free survival after complete response in patients treated with this regimen
Correlate molecular markers with outcome in patients treated with this regimen
Determine the effects of this regimen on neurological function in these patients
OUTLINE This is a multicenter study
Induction Chemotherapy All induction therapy courses repeat every 28 days
Courses 1-3 Patients receive high-dose methotrexate IV over 4 hours on days 1 and 15 leucovorin calcium IV or orally every 6 hours beginning on days 2 and 16 and continuing until blood levels of methotrexate are in a safe range and oral temozolomide on days 7-11 Patients also receive rituximab IV on days 3 10 17 and 24 of course 1 and days 3 and 10 of course 2 total of 6 doses
NOTE Patients diagnosed with T-cell primary CNS lymphoma do not receive rituximab
Course 4 Patients receive oral temozolomide on days 7-11 high-dose methotrexate IV over 4 hours on day 15 and leucovorin calcium IV or orally every 6 hours beginning on day 16 and continuing until blood levels of methotrexate are in a safe range Patients achieving a complete response or a complete response unconfirmed proceed to consolidation therapy
Consolidation therapy I course 5 Beginning 4 weeks after the start of course 4 patients receive high-dose methotrexate IV over 4 hours on day 1 leucovorin calcium IV or orally every 6 hours beginning on day 2 and continuing until blood levels of methotrexate are in a safe range and oral temozolomide on days 7-11
Consolidation therapy II course 6 Beginning 3-5 weeks after the start of course 5 patients receive cytarabine IV over 2 hours twice daily and etoposide IV over 12 hours twice daily on days 1-4 and filgrastim G-CSF or sargramostim GM-CSF subcutaneously beginning on day 14 and continuing until blood counts recover
Treatment continues in the absence of disease progression
After completion of study treatment patients are followed periodically for 3 years
PROJECTED ACCRUAL A total of 27-45 patients will be accrued for this study within 2-3 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CALGB-50202 | None | None | None |
| CDR0000398106 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |