Intra-pemetrexed Alone or Combined With Concurrent Radiotherapy for Leptomeningeal Metastasis
Status:
Recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
Intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal
metastases. Owing to the limited number of agents available for intrathecal chemotherapy, it
is crucial to find a novel agent with efficacy and safety. In our phase 1 study, intrathecal
pemetrexed showed controllable toxicities and potential promising efficacy for refractory
leptomeningeal metastases from non-small-cell lung cancer patients. In our further study,
intrathecal pemetrexed combined with involved-field radiation therapy was administered as the
first-line intrathecal chemotherapy for leptomeningeal metastases from solid tumors. In this
study, intrathecal pemetrexed combined with involved-field radiation therapy showed
feasibility and controllable adverse events. It has been proved that pemetrexed as a novel
intrathecal drug exhibited promising antitumor effects in cerebrospinal fluid. Moreover, the
concomitant therapeutic modality is an optimal treatment option for leptomeningeal metastases
from solid tumors.
Central nervous system radiotherapy is a part of the specific treatment of leptomeningeal
metastases. Radiotherapy has been proved to improve neurologic function and control of
parenchymal brain metastases in leptomeningeal metastases treatment. Additionally,
radiotherapy is revealed to improve the efficacy and attenuate toxicity of intrathecal
chemotherapy as a result of normal cerebrospinal fluid reestablishing. However, it is still
controversial whether radiotherapy can improve the overall survival. We conduct this study to
further demonstrate the efficacy and safety of intrathecal pemetrexed administration for
patients with leptomeningeal metastases from solid tumors by multicenter study. Furthermore,
the study of effective treatment modality is of great significance. The safety and antitumor
activity of intrathecal pemetrexed combined with involved-field radiation therapy and
intrathecal pemetrexed alone were also compared to confirm an optimized therapeutic regimen.
Phase:
N/A
Details
Lead Sponsor:
The First Hospital of Jilin University
Collaborators:
Guangdong 999 Brain Hospital Second Affiliated Hospital of Guangzhou Medical University The Affiliated Hospital of Guangdong Medical College The Second Hospital of Hebei Medical University