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New treatment option for Leptomeningeal Metastasis From Lung Cancer
Official title Exploration of the Application of Methotrexate-loaded Drug Vesicles in Intrathecal Injection for Meningeal Metastasis of Lung Cancer
ClinicalTrials.gov ID: NCT07559097
What this study is testing
What is Methotrexate-loaded vesicles?
Methotrexate-loaded vesicles is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for leptomeningeal metastasis from lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase I/II, single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, and preliminary efficacy of intrathecal injection of methotrexate-loaded autologous tumor cell-derived microparticles (MTX-MPs) in patients with leptomeningeal metastasis from lung cancer who have failed standard of care. The study consists of two phases: Phase I employs an accelerated titration combined with a "3+3" dose-escalation design to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Participants can be enrolled in this study only if they meet all of the following
- Age ≥ 18 years old;
- Diagnosed with lung cancer by pathological biopsy or cytology;
- Diagnosed with meningeal metastasis by detecting tumor cells in cerebrospinal fluid cytology;
- Patients with advanced lung cancer and meningeal metastasis who have failed standard treatment;
You likely can't join if
- \- The following conditions will disqualify a patient from participating in this study:
- Concurrent central nervous system infectious diseases;
- ECOG PS ≥ 4;
- Patients currently participating in other treatment studies;
- History of or current severe immunodeficiency diseases;
- Any other conditions that, in the judgment of the researcher, make the patient unfit to participate in this study.
See the full eligibility criteria
- \- Participants can be enrolled in this study only if they meet all of the following
- Age ≥ 18 years old;
- Diagnosed with lung cancer by pathological biopsy or cytology;
- Diagnosed with meningeal metastasis by detecting tumor cells in cerebrospinal fluid cytology;
- Patients with advanced lung cancer and meningeal metastasis who have failed standard treatment;
- ECOG PS 0 - 3.
- \- The following conditions will disqualify a patient from participating in this study:
- Concurrent central nervous system infectious diseases;
- ECOG PS ≥ 4;
- Patients currently participating in other treatment studies;
- History of or current severe immunodeficiency diseases;
- Any other conditions that, in the judgment of the researcher, make the patient unfit to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.