Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072449
Status:
TERMINATED
Last Update Posted:
2013-08-28
First Post:
2003-11-04
Brief Title:
Rituximab in Treating Patients With Refractory or Relapsed Primary CNS 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 Anti-CD20 Monoclonal Antibody Rituximab Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma PCNSL
Status:
TERMINATED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual and lack of resources and 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 locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of rituximab in treating patients who have refractory or relapsed primary CNS lymphoma
PURPOSE Phase II trial to study the effectiveness of rituximab in treating patients who have refractory or relapsed primary CNS lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the radiographic response proportion in patients with refractory or recurrent primary CNS lymphoma treated with rituximab
Secondary
Determine the progression-free and overall survival of patients treated with this drug
Determine the toxicity profile of this drug in these patients
OUTLINE This is a multicenter study
Patients receive rituximab IV on days 1 8 15 and 22 Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients may receive additional courses of rituximab off study at the discretion of the treating physician
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study within 5-9 months
Primary
Determine the radiographic response proportion in patients with refractory or recurrent primary CNS lymphoma treated with rituximab
Secondary
Determine the progression-free and overall survival of patients treated with this drug
Determine the toxicity profile of this drug in these patients
OUTLINE This is a multicenter study
Patients receive rituximab IV on days 1 8 15 and 22 Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients may receive additional courses of rituximab off study at the discretion of the treating physician
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study within 5-9 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 |
|---|---|---|---|
| U01CA062475 | NIH | None | None |
| NABTT-2201 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01CA062475 |