Clinical trial · Interventional
Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease
Characterization of the Pharmacokinetics and Efficacy of Intraventricular Methotrexate Continuously Delivered Via a Mini Pump for Treatment of Leptomeningeal Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
This pilot clinical trial studies continuous intraventricular methotrexate in treating patients with leptomeningeal disease. Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the ventricles may be an effective treatment for patients with leptomeningeal disease
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leptomeningeal Metastases | Meningeal Carcinomatosis | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| methotrexate | Drug | Methotrexate | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (intraventricular chemotherapy)
- description
- Patients receive intraventricular methotrexate continuously on days 1-14. Treatment continues in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: pharmacological study
- Drug: methotrexate
Primary outcomes (2)
- measure
- Efficacy of continuously delivered intraventricular methotrexate
- timeFrame
- Day 3 after start of treatment
- description
- The concentration of methotrexate in the brain parenchyma will be determined with microdialysis probe placed next to the ventricle.
- measure
- Pharmacokinetics of continuous intraventricular infusion of methotrexate
- timeFrame
- Day 14 after start of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with leptomeningeal carcinomatosis (from solid tumors) * Subjects with lymphomatous or leukemic meningitis * The effects of methotrexate on the developing fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following the conclusion of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she will be excluded from the study and should inform her treating physical immediately * Karnofsky Performance Status greater than 70% * All subjects must have the ability to understand and the willingness to sign a written informed consent * We will exclude subjects who have had prior intrathecal/intraventricular therapy with methotrexate within 6 months Exclusion Criteria: * Prior therapy with methotrexate for management of leptomeningeal disease * Subjects with evidence of hydrocephalous * Subjects with intraparenchymal lesions or bulky disease * Subjects with ventriculoperitoneal shunt in place * Previous history of whole brain radiation therapy * Subjects who, in the opinion of the principal investigator, may not be able to comply with the safety monitoring requirements of the study will not be included in this trial
References
Publications (0)
Data not yet available