Status:
COMPLETED
Intrathecal Pemetrexed for Leptomeningeal Metastasis
Lead Sponsor:
The First Hospital of Jilin University
Collaborating Sponsors:
Affiliated Hospital of Guangdong Medical University
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Leptomeningeal Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Intrathecal chemotherapy is one of the most important treatment modalities for leptomeningeal metastasis of solid tumors. In the previous study(Intrathecal Pemetrexed for Recurrent Leptomeningeal Meta...
Detailed Description
This is a phase I/II clinical trial. The objective of the study is patients with leptomeningeal metastases from solid tumors. Pemetrexed (Alimta, Eli Lilly and Company) is administrated by intrathecal...
Eligibility Criteria
Inclusion
- Patients who have been definitely diagnosed as leptomeningeal metastasis according to cerebrospinal fluid cytology or neuroimaging, or patients who got the clinical diagnosis by combining with the history of cancer, clinical manifestation, cerebrospinal fluid examination, neuroimaging etc.;
- Patients who have been diagnosed as malignant solid tumor according histopathology or cytopathology combined with imaging;
- No prior intrathecal chemotherapy;
- Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3;
- No other severe chronic diseases;
- No history of severe nervous system disease;
- No severe dyscrasia.
Exclusion
- Patients receiving molecularly targeted drugs that are effective in treating leptomeningeal metastases within 2 weeks prior to enrollment;
- Patients with hydrocephalus or other factors suggestive of cerebrospinal fluid circulation obstruction;
- patients with serious central nervous system disorders including severe encephalopathy, moderate or severe coma, and Glasgow Coma Score of \<8 points;
- Patients who have been diagnosed as hematological malignancy or primary central germ cell tumor;
- Other reasons that were unsuitable for this study, including patients with lethal or extensive systemic diseases with few treatment options,psychiatric illness and poor compliance.
Key Trial Info
Start Date :
February 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05289908
Start Date
February 21 2022
End Date
March 31 2024
Last Update
May 4 2025
Active Locations (1)
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1
The First Hospital of Jilin University
Changchun, Jilin, China, 130021