Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424242
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2007-01-16
Brief Title:
Pemetrexed Disodium in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Pharmacokinetic Study of Pemetrexed in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
Status:
COMPLETED
Status Verified Date:
2021-09
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 Pemetrexed disodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Studying samples of cerebrospinal fluid and blood from patients with cancer in the laboratory may help doctors learn how pemetrexed disodium works in the body and identify biomarkers related to cancer
PURPOSE This clinical trial is studying the side effects and how well pemetrexed disodium works in treating patients with leptomeningeal metastases
PURPOSE This clinical trial is studying the side effects and how well pemetrexed disodium works in treating patients with leptomeningeal metastases
Detailed Description:
OBJECTIVES
Determine the cerebrospinal fluid CSFplasma ratio of pemetrexed disodium at different IV dose levels in patients with leptomeningeal metastases
Determine the safety of this drug in these patients
Determine the antitumor activity of this drug in these patients
Assess the role of CSF vascular endothelial growth factor and YKL 40 as markers of response andor prognosis in these patients
OUTLINE Patients receive pemetrexed disodium IV over 10 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients undergo lumbar puncture and blood collection prior to therapy and 30-60 minutes after the first dose of pemetrexed disodium for pharmacological studies Patients with Ommaya reservoirs undergo cerebrospinal fluid CSF collection at baseline and 025 050 1 2 4 6 and 80 hours after pemetrexed disodium administration CSF is then obtained once during each subsequent course of study treatment CSF and blood are also evaluated for YKL 40 and vascular endothelial growth factor
After completion of study therapy patients are followed every 2-3 months
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study
Determine the cerebrospinal fluid CSFplasma ratio of pemetrexed disodium at different IV dose levels in patients with leptomeningeal metastases
Determine the safety of this drug in these patients
Determine the antitumor activity of this drug in these patients
Assess the role of CSF vascular endothelial growth factor and YKL 40 as markers of response andor prognosis in these patients
OUTLINE Patients receive pemetrexed disodium IV over 10 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients undergo lumbar puncture and blood collection prior to therapy and 30-60 minutes after the first dose of pemetrexed disodium for pharmacological studies Patients with Ommaya reservoirs undergo cerebrospinal fluid CSF collection at baseline and 025 050 1 2 4 6 and 80 hours after pemetrexed disodium administration CSF is then obtained once during each subsequent course of study treatment CSF and blood are also evaluated for YKL 40 and vascular endothelial growth factor
After completion of study therapy patients are followed every 2-3 months
PROJECTED ACCRUAL A total of 15 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 |
|---|---|---|---|
| STU00004482 | OTHER | Northwestern University IRB | None |