Ignite Creation Date:
2024-05-11 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399926
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-03-18
Brief Title:
Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir
Sponsor:
Xiangya Hospital of Central South University
Organization:
Xiangya Hospital of Central South University
Study Overview
Official Title:
A Open-label Random Multi-central Prospective Cohort of Observation Study on the Efficacy and Safety of Intraventricule Pemetrexed Disodium Via Ommaya Reservoir
Status:
RECRUITING
Status Verified Date:
2024-04
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 is a open-label multi-center prospective observation study for the efficacy and safety of intraventricle pemetrexed disodium via ommaya reservoir in the treatment of leptomeningeal metastasis with lung cancer who have failed at least one targeted therapy In detail At least the treatment failure was after third-generation EGFR-TKIs in EGFR-mutated lung cancer or at least the treatment failure was after second-generation ALK-TKIs in ALK-mutated lung cancer or at least the treatment failure was after one-line of targeted-TKIs in ROS1-mutated non-squamous non-small lung cancer
Detailed Description:
Participants were randomizedly assigned in cohort 1 who will be given pemetrexed 20mg every 24 hours for 72 hours every 2 weeksor in cohort 2 will be given pemetrexed 30mg once a week
It was designed for two stages on treatment course Induction therapy Efficacy evaluation every 2 cycles and confirm the efficacy at the next cycle If at the next cycle the efficacy result changed such as SD or PR after initial PD or PD after initial SD or PR the second time of efficacy assess was required If the CSF cytology at the time of the efficacy evaluation was negative one more cycle was required to confirm the CSF cytology
Consolidation If the efficacy is remissionincluding complete remission obvious remission or partial remission or stable disease for initial timepoint and the timepoint of the confirmed evaluation then the patient will be advanced to the stage of consolidation treatment Participants in cohort 1 who will be given pemetrexed 20mg every 24 hours for 72 hours every 3 weeks Participants in cohort 2 will be given pemetrexed 30mg every 3 weeks Until the toxicity is intolerable or disease progression
Cross over Compared the first 4 enrolled cases in each group the comprehensive evaluationincluding efficacy cytology negative toxicity in better group50 higher efficacy or 50 less toxicity will be the following cohort to which the other one will crossover
It was designed for two stages on treatment course Induction therapy Efficacy evaluation every 2 cycles and confirm the efficacy at the next cycle If at the next cycle the efficacy result changed such as SD or PR after initial PD or PD after initial SD or PR the second time of efficacy assess was required If the CSF cytology at the time of the efficacy evaluation was negative one more cycle was required to confirm the CSF cytology
Consolidation If the efficacy is remissionincluding complete remission obvious remission or partial remission or stable disease for initial timepoint and the timepoint of the confirmed evaluation then the patient will be advanced to the stage of consolidation treatment Participants in cohort 1 who will be given pemetrexed 20mg every 24 hours for 72 hours every 3 weeks Participants in cohort 2 will be given pemetrexed 30mg every 3 weeks Until the toxicity is intolerable or disease progression
Cross over Compared the first 4 enrolled cases in each group the comprehensive evaluationincluding efficacy cytology negative toxicity in better group50 higher efficacy or 50 less toxicity will be the following cohort to which the other one will crossover
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