Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543992
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate Via the Ommaya Reservoir in Breast Cancer With Leptomeningeal Metastasis a Phase II Multicenter Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis
Detailed Description:
This was a II single-arm prospective multicenter study designed to estimate the efficacy and safety of intrathecal administration of thiotepa in combination with methotrexate via the Ommaya Reservoir in breast cancer with leptomeningeal metastasis
The primary end point was iORR complete response CR partial response PR according to RANO-LM Scoring based on radiographic assessment in leptomeningeal metastases A composite score total score is calculated and compared with the baseline total score A 25 worsening in the current score relative to baseline defines radiographic progressive disease A 50 improvement in the current score defines a radiographic partial response Resolution of all baseline radiographic abnormalities defines a complete response All other situations define stable disease The secondary end points were changes in iPFS iDoR ORR PFS OS DoR and exploratory analysis of the relationship between molecular markers and therapeutic efficacy
This study is planned to include 22 patients with leptomeningeal metastasis from breast cancer who meet the entry criteria
The primary end point was iORR complete response CR partial response PR according to RANO-LM Scoring based on radiographic assessment in leptomeningeal metastases A composite score total score is calculated and compared with the baseline total score A 25 worsening in the current score relative to baseline defines radiographic progressive disease A 50 improvement in the current score defines a radiographic partial response Resolution of all baseline radiographic abnormalities defines a complete response All other situations define stable disease The secondary end points were changes in iPFS iDoR ORR PFS OS DoR and exploratory analysis of the relationship between molecular markers and therapeutic efficacy
This study is planned to include 22 patients with leptomeningeal metastasis from breast cancer who meet the entry criteria
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