Intrathecal methotrexate-loaded tumor-derived vesicles for leptomeningeal lung cancer
A Phase I/II, Single-arm, Single-center Clinical Study: Exploration of the Application of Methotrexate-loaded Drug Vesicles in Intrathecal Injection for Meningeal Metastasis of Lung Cancer
This treatment will try giving methotrexate-loaded tumor-derived vesicles into the spinal fluid to see if it is safe and helps adults with leptomeningeal metastasis from lung cancer who have not responded to standard treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT07559097 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with pathologically confirmed lung cancer and cytology-proven leptomeningeal metastasis who have failed standard treatments and have ECOG performance status 0–3 are the intended participants.
Not a fit: Patients with active central nervous system infections, severe immunodeficiency, ECOG ≥4, current participation in other interventional studies, or other conditions judged by investigators to preclude safe participation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve control of leptomeningeal disease and neurological symptoms by delivering higher methotrexate concentrations into the cerebrospinal fluid with potentially less systemic toxicity.
How similar studies have performed: While intrathecal methotrexate has been used historically for leptomeningeal disease, delivery via methotrexate-loaded autologous tumor cell-derived microparticles is a novel method with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 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: \- 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 this trial is running
Zhengzhou, Henan
- Wang Qiming — Zhengzhou, Henan, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.