leptomeningeal metastases from lung adenocarcinoma
Conditions
Interventions
Ommaya reservoir treatment arm:Intracerebral injection of pemetrexed, 20–50 mg (dissolved in 5 ml of normal saline, based on the patient’s body surface area and ECOG score), once every 3 weeks. The do
after the injection, instruct the patient to lie flat for 2 hours.
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. ECOG performance status 0–3; 3. Histologically or cytologically confirmed lung adenocarcinoma; 4. Participants with a confirmed diagnosis of meningeal metastases based on the ‘EANO-ESMO’ diagnostic criteria for meningeal metastases, following a comprehensive clinical assessment comprising symptom assessment, imaging assessment and/or cerebrospinal fluid pathological assessment; 5. Intracranial progression following prior systemic therapy (including targeted therapy, immunotherapy and chemotherapy), or inability to tolerate or unsuitability for systemic therapy; 6. An Ommaya pouch must be in place, and the ventricular catheter must be patent; 7. Subjects with meningeal progression combined with parenchymal progression are eligible for enrolment; 8. If neurological symptoms are present, the following condition must be met: no increase in corticosteroid dosage is required to enhance control of central nervous system symptoms for at least 1 week prior to study treatment. If the patient is receiving corticosteroids for the treatment of endocrine dysfunction or tumour-related symptoms (not related to the central nervous system), the dosage must be stable or reduced within 5 days prior to study treatment. Note: Corticosteroid dosage must be stable for 5 days prior to the baseline brain MRI; 9. Prior to commencement of study treatment, all toxicity reactions related to anticancer therapy (including radiotherapy) must have resolved to Grade =8 weeks; 11. Patients must meet the following criteria at screening: (1) Neutrophil count >=1.5 × 10?/L (2) Platelet count >=100 × 10?/L (3) Haemoglobin >= 90 g/L (4) Serum creatinine =50 mL/min (5) Total serum bilirubin <= 1.5 × ULN (for patients with Gilbert’s syndrome or liver metastases, <= 3 × ULN is permitted) (6) AST <= 2.5 x ULN (for patients with liver metastases, <= 5 x ULN is permitted); (7) ALT <= 2.5 x ULN (for patients with liver metastases, <= 5 x ULN is permitted); 12. The subject has fully understood and voluntarily signed the Informed Consent Form (ICF);
Exclusion criteria
Exclusion criteria: 1.Active intracranial infection or infection at Ommaya reservoir site. 2.Severe uncontrolled systemic disease. 3.Major surgery (e.g., intrathoracic, intra-abdominal, or intrapelvic surgery) within 4 weeks prior to the first dose of study treatment, or failure to recover from surgery-related adverse effects. 4.Presence of other malignancies besides NSCLC, or a history of other malignancies within the past 5 years, with the exception of completely resected basal cell and squamous cell carcinoma of the skin, and curatively resected carcinoma in situ of any type. 5.Known allergy or hypersensitivity to pemetrexed or any of its excipients. 6.Pregnant or breastfeeding women. 7.Prior or concurrent HIV infection. 8.Any other condition that, in the investigator's judgment, would preclude participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial objective response rate (iORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Changes in neurocognitive function scores and quality?of?life (QoL) scale scores.;Intracranial progression-free survival (iPFS);Adverse event incidence and severity;Intracranial disease control rate (iDCR); | — |
Countries
China
Contacts
Public ContactChen Xiaoxia
Shanghai Pulmonary Hospital
Outcome results
None listed