Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248534
Status:
TERMINATED
Last Update Posted:
2018-09-04
First Post:
2005-11-03
Brief Title:
Rituximab Temozolomide and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkins Lymphoma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase II Study of Rituximab and Temozolomide in Recurrent Primary CNS Lymphoma
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accruallack of resourceslow priority due to combining 2 consortia
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE 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 Drugs used in chemotherapy such as temozolomide and methylprednisolone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Rituximab may help chemotherapy kill more cancer cells by making cancer cells more sensitive to the drugs Giving rituximab together with temozolomide and methylprednisolone may be an effective treatment for primary CNS non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving rituximab together with temozolomide and methylprednisolone works in treating patients with recurrent primary CNS non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving rituximab together with temozolomide and methylprednisolone works in treating patients with recurrent primary CNS non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with recurrent primary CNS non-Hodgkins lymphoma treated with rituximab temozolomide and methylprednisolone
Secondary
Determine the overall and 6-month progression-free survival of patients treated with this regimen
OUTLINE Induction therapy Patients receive rituximab IV over 30-60 minutes on days 1 8 15 and 22 and oral temozolomide daily on days 1-7 and 15-21 After day 28 patients with stable disease or better proceed to consolidation therapy
Consolidation therapy Patients receive oral temozolomide daily on days 1-5 Treatment repeats every 28 days for up to 6 courses Patients achieving a complete remission proceed to maintenance therapy
Maintenance therapy Patients receive methylprednisolone IV over 2 hours on day 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within approximately 133 months
Primary
Determine the response rate in patients with recurrent primary CNS non-Hodgkins lymphoma treated with rituximab temozolomide and methylprednisolone
Secondary
Determine the overall and 6-month progression-free survival of patients treated with this regimen
OUTLINE Induction therapy Patients receive rituximab IV over 30-60 minutes on days 1 8 15 and 22 and oral temozolomide daily on days 1-7 and 15-21 After day 28 patients with stable disease or better proceed to consolidation therapy
Consolidation therapy Patients receive oral temozolomide daily on days 1-5 Treatment repeats every 28 days for up to 6 courses Patients achieving a complete remission proceed to maintenance therapy
Maintenance therapy Patients receive methylprednisolone IV over 2 hours on day 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within approximately 133 months
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 |
|---|---|---|---|
| U01CA062399 | NIH | CTRP Clinical Trials Reporting System | httpsreporternihgovquickSearchU01CA062399 |
| NABTC-05-01 | None | None | None |
| CDR0000445289 | REGISTRY | None | None |
| NCI-2012-02673 | REGISTRY | None | None |