Ignite Creation Date:
2024-07-17 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497543
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-05
Brief Title:
Intrathecal Pemetrexed for SCLC Patients With Refractory Brain Metastases or Leptomeninges Metastatic
Sponsor:
Hunan Province Tumor Hospital
Organization:
Hunan Province Tumor Hospital
Study Overview
Official Title:
The Efficacy and Safety of Intrathecal Pemetrexed for SCLC Patients With Refractory Brain Metastases or Leptomeningeal Metastasis A Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed for SCLC patients with refractory brain metastases or leptomeningeal metastasis
Detailed Description:
This is a prospective interventional clinical study to evaluate the efficacy and safety of intrathecal pemetrexed for SCLC patients with refractory brain metastases or leptomeningeal metastasis Approximately 80 small cell lung cancer patients with refractory brain andor leptomeningeal metastasis were enrolled and treated with intrathecal pemetrexed there were 40 cases in cohort 1 with refractory brain metastasis and 40 cases in cohort 2 with leptomeningeal metastasisCerebrospinal fluid samples will be collected before and after pemetrexed resistance to analyze molecular mechanisms The study is expected to commence recruitment in mainland China in about September 2024 It is expected that the trial will end in April 2026
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None