Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastases From Non-small Cell Lung Cancer
Status:
Completed
Trial end date:
2019-01-05
Target enrollment:
Participant gender:
Summary
It has been proved that intrathecal chemotherapy is the main treatment strategy for
leptomeningeal metastases. At present, the commonly used drugs for intrathecal chemotherapy
include methotrexate, cytarabine, and liposomal cytarabine. In recent decades, no new
effective drugs have been discovered for intrathecal chemotherapy. The recurrence of
leptomeningeal metastases is inevitable even after aggressive treatment. There is no
effective treatment for recurrent leptomeningeal metastases after comprehensive treatment
which includes intrathecal methotrexate and/or cytarabine, central nervous system radiation
therapy, systemic chemotherapy as well as tyrosine-kinase inhibitor drugs. The quality of
life is extremely poor, and the patients always die in short time. Pemetrexed is a newer
multitargeted antifolate which has shown activity in various tumors. It has higher
effectiveness and safety, which has been used as the first-line treatment of non-small cell
lung cancer. In animal studies, pemetrexed was demonstrated to suppress tumor growth
completely in mice with two types of transplanted human colon xenografts resistant to
methotrexate. Therefore, the purpose of the study is to evaluate the safety and feasibility
of intrathecal pemetrexed in patients with recurrent leptomeningeal metastases from non-small
cell lung cancer.
Phase:
Phase 1
Details
Lead Sponsor:
First Hospital of Jilin University The First Hospital of Jilin University