Trial reportJournal of neuro-oncology2025
Intrathecal pemetrexed for newly diagnosed leptomeningeal metastases: a multicenter, open-label, phase I/II study.
Trial report in Journal of neuro-oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05289908 (Phase I/II Clinical Trial of Intrathecal Pemetrexed as First Line Intrathecal Chemotherapy in Patients With Leptomeningeal Metastasis), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase I/II Clinical Trial of Intrathecal Pemetrexed as First Line Intrathecal Chemotherapy in Patients With Leptomeningeal Metastasis
Who cites it
1 citing paper in PubMed.
- The immune landscape of cerebrospinal fluid across brain malignancies.Neuro-oncology advancesReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
purposeThis phase I/II study aimed to determine the maximum-tolerated dose (MTD) of intrathecal pemetrexed (IP) with vitamin supplementation, and to evaluate its safety, feasibility and therapeutic activity for newly diagnosed leptomeningeal metastasis (LM) from solid tumors.
methodsThe phase I study followed the classic 3 + 3 design, with IP dose escalating from 15 mg. The recommended dose was applied in the phase II study. IP was administered first as induction therapy twice weekly for 2 weeks, followed by consolidation therapy, once weekly for 4 weeks, then maintenance therapy once monthly. Vitamin supplementation was initiated prior to the first IP dose. The MTD, adverse events (AEs), overall survival (OS), clinical response rate (CRR) and disease control rate (DCR) were evaluated.
resultsA total of 34 patients were enrolled. In the phase I study, 2 patients in the 20 mg group experienced dose-limiting toxicity, including grade 4 leukopenia and grade 5 chemical arachnoiditis. The MTD was established as 15 mg. Among 28 patients in the MTD group, 24 completed induction therapy, 19 completed consolidation therapy and 11 proceeded to maintenance therapy. The overall AEs rate was 74% (25/34), and severe AEs rate (> grade 3) was 15% (5/34). In the MTD group, the CRR, DCR and median OS were 46% (13/28), 75% (21/28) and 8.1 months (95% CI, 6.5-11.9).
conclusionIP at 15 mg, with folic acid and vitamin B12 supplementation initiated before the first IP dose, demonstrated feasibility and exhibited controllable toxicity. This regimen offers a new treatment option with therapeutic activity for newly diagnosed LM patients with solid tumors.
trial registrationClinicalTrials.gov Identifier NCT05289908.
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