Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416923
Status:
COMPLETED
Last Update Posted:
2015-02-16
First Post:
2006-12-27
Brief Title:
Intrathecal Rituximab in Treating Patients With Recurrent CNS Lymphoma
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Phase I Study of Intrathecal Rituximab in Patients With Recurrent CNS Lymphoma
Status:
COMPLETED
Status Verified Date:
2015-02
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 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 intrathecally may be an effective treatment for recurrent CNS lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of intrathecal rituximab in treating patients with recurrent CNS lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of intrathecal rituximab in treating patients with recurrent CNS lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety and pharmacokinetics of intrathecal rituximab in patients with recurrent CNS lymphoma arising from CD20 B-cell non-Hodgkins lymphoma
Secondary
Determine the efficacy of intrathecal rituximab
Determine the molecular pathogenesis of lymphomatous meningitis
Determine the molecular basis for response or lack of response to rituximab
Identify molecular markers specific for lymphomatous meningitis that will be useful for prognostic evaluation of peripheral lymphomas
Determine the quality of life of patients treated with intrathecal rituximab
OUTLINE This is a dose-escalation multicenter study
Patients receive rituximab intrathecally over 10 minutes on day 1 in week 1 and on days 1 and 4 in weeks 2-5 in the absence of disease progression or unacceptable toxicity Patients achieving at least a partial response with no rituximab-related neurotoxicity may continue to receive treatment beyond 5 weeks
Cohorts of patients receive escalating doses of rituximab until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which fewer than 13 of patients experience dose-limiting toxicity
Quality of life is assessed at baseline and at the completion of study treatment
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
Primary
Determine the safety and pharmacokinetics of intrathecal rituximab in patients with recurrent CNS lymphoma arising from CD20 B-cell non-Hodgkins lymphoma
Secondary
Determine the efficacy of intrathecal rituximab
Determine the molecular pathogenesis of lymphomatous meningitis
Determine the molecular basis for response or lack of response to rituximab
Identify molecular markers specific for lymphomatous meningitis that will be useful for prognostic evaluation of peripheral lymphomas
Determine the quality of life of patients treated with intrathecal rituximab
OUTLINE This is a dose-escalation multicenter study
Patients receive rituximab intrathecally over 10 minutes on day 1 in week 1 and on days 1 and 4 in weeks 2-5 in the absence of disease progression or unacceptable toxicity Patients achieving at least a partial response with no rituximab-related neurotoxicity may continue to receive treatment beyond 5 weeks
Cohorts of patients receive escalating doses of rituximab until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which fewer than 13 of patients experience dose-limiting toxicity
Quality of life is assessed at baseline and at the completion of study treatment
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 10 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 |
|---|---|---|---|
| GENENTECH-UCSF-01302 | None | None | None |
| UCSF-01302 | None | None | None |
| UCSF-H9414-19588-04 | None | None | None |
| UCSF-U2337S | None | None | None |