lung cancer with leptomeningeal metastases
Conditions
Interventions
Intervention group:Intrathecal pemetrexed via an Ommaya reservoir+ Oral HGWD
Control group:Intrathecal pemetrexed via an Ommaya reservoir
Sponsors
Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The age is >= 18 years old and = 3 months. 5. Patients must meet the following hematological indicators: a) absolute neutrophil count (ANC) >= 1.5 x 10^9 g/dL b) hemoglobin (HB) >= 9.0 g/dL c) platelet count (PLT) >= 100 x 10^9 /L 6. Patients must meet the following biochemical indicators: a) serum total bilirubin (TBIL) = 60 mL/min 7. No obvious bleeding symptoms, hemorrhagic diseases, or thrombotic diseases; 8. Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age should take effective contraceptive measures during the whole treatment period. 9. Patients should sign a written informed consent form. 10. Patients should be able to comply with the follow up and related procedures stipulated in the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to pemetrexed, or have contraindications to pemetrexed. 2. Received systemic treatment, including EGFR-TKIs, systemic chemotherapy, intrathecal chemotherapy and whole-brain radiotherapy (WBRT) within 2 weeks before the first therapy. 3. Patients who have uncontrollable epilepsy. 4. Patients who have a history of other tumors at the same time. 5. Bleeding and thrombus tendency (hemophilia patients, clotting dysfunction, platelet reduction, and so on), and coagulant function abnormality (international standardized ratio (INR) > 2, prothrombin time (PT) > 16s) are known. Patients who have recently received antithrombotic or anticoagulant therapy, except the preventative use of small-dose aspirin and low-molecular heparin. 6. Patients who have undergone major surgery or trauma in the 1 months prior to inclusion. Patients who have significant clinical bleeding symptoms in the 3 months prior to inclusion. 7. Any arterial / venous thromboembolic events occurred in the 6 months prior to inclusion, including cerebrovascular accident (transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, pulmonary embolism, and so on. 8. Severe liver and kidney dysfunction, HIV infection, HCV infection, asthma and uncontrollable cerebrovascular disease are known. 9. Female patients who are pregnant or breastfeeding. 10. Patients who can't comply with the follow up and related procedures stipulated in the protocol. 11. Patients who the researchers did not consider suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| neurotoxicity;NCI Common Toxicity Criteria CTC 3.0; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Progression-free survival (PFS); | — |
Countries
China
Contacts
Public ContactZhenyu Yin
Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Outcome results
None listed