RecruitingNCT06399926

Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir

A Open-label, Random, Multi-central Prospective Cohort of Observation Study on the Efficacy and Safety of Intraventricule Pemetrexed Disodium Via Ommaya Reservoir


Sponsor

Xiangya Hospital of Central South University

Enrollment

64 participants

Start Date

Oct 30, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a chemotherapy drug (pemetrexed) delivered directly into the fluid surrounding the brain and spinal cord — through a small implanted device called an Ommaya reservoir — can treat lung cancer that has spread to the lining of the brain (leptomeningeal metastasis). **You may be eligible if...** - You have non-squamous non-small cell lung cancer with a confirmed genetic mutation (EGFR, ALK, or ROS1) - Your lung cancer has spread to the lining of the brain, confirmed by tests - You have already tried multiple targeted therapy drugs (TKIs) without success - You are medically able to have an Ommaya reservoir implanted **You may NOT be eligible if...** - You are HIV positive - You have rapidly progressing cancer outside the brain that cannot be controlled - You are extremely malnourished or have end-stage disease - You have severe problems from brain tumors outside the meninges - You have another active cancer - You have very poor kidney, liver, or blood function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPemetrexed injection

Group 1(20mg):induction stage is 20 mg per 24 hours for 72 hours, every 2 weeks; consolidation stage is 20mg per 24 hours for 72 hours, every 3 weeks.

DRUGPemetrexed

Group 2(30mg):induction stage is 30 mg D1,every week.Consolidation stage is 30 mg D1,every 3 weeks.


Locations(1)

Xiangya Hospital Central South University

Changsha, Hunan, China

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NCT06399926


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