Intrathecal methotrexate-loaded tumor-derived vesicles for leptomeningeal lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label Phase I/II trial testing intrathecal methotrexate-loaded autologous tumor cell-derived microparticles (MTX-MPs) in patients with cytologically confirmed leptomeningeal metastasis from lung cancer who have failed standard care. Phase I uses an accelerated titration combined with a 3+3 dose-escalation design to define the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D), and Phase II measures objective response rate (ORR) at the RP2D. About 10–20 adults (age ≥18, ECOG PS 0–3) will receive MTX-MPs on days 1, 3, and 5 of the first cycle and then every three weeks until disease progression. Key secondary endpoints include progression-free survival, overall survival, and a detailed safety profile.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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Participants can be enrolled in this study only if they meet all of the following inclusion criteria:

1. Age ≥ 18 years old;
2. Diagnosed with lung cancer by pathological biopsy or cytology;
3. Diagnosed with meningeal metastasis by detecting tumor cells in cerebrospinal fluid cytology;
4. Patients with advanced lung cancer and meningeal metastasis who have failed standard treatment;
5. ECOG PS 0 - 3.

Exclusion Criteria:

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The following conditions will disqualify a patient from participating in this study:

1. Concurrent central nervous system infectious diseases;
2. ECOG PS ≥ 4;
3. Patients currently participating in other interventional studies;
4. History of or current severe immunodeficiency diseases;
5. Any other conditions that, in the judgment of the researcher, make the patient unfit to participate in this study.

Where it's running

• Wang Qiming
  Zhengzhou, Henan, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.