34
Participants
Start Date
February 21, 2022
Primary Completion Date
March 20, 2023
Study Completion Date
March 31, 2024
Pemetrexed (1)
Pemetrexed (Alimta, Eli Lilly and Company) is administrated by intrathecal injection, plus dexamethasone, twice per week for 2 weeks, followed by once per week for 4 weeks. The initial dose of intrathecal pemetrexed is 15 mg, escalated to 20 mg, and then 25 mg....
Pemetrexed (2)
The maximum-tolerated dose determined in phase I study is chosen as the treatment dose in phase II study.
Folic Acid
Folic acid 200-400 μg is administered orally once daily, prior to the first intrathecal pemetrexed, until 21 days after the last intrathecal pemetrexed.
Vitamin B12
A single dose of vitamin B12 1000 μg is administered by intramuscular injection before the first intrathecal pemetrexed, once per 3 weeks.
Dexamethasone
Dexamethasone, 5 mg, intrathecal injection via lumbar puncture, simultaneously with pemetrexed, twice per week for 2 weeks, followed by once per week for 2-4 weeks.
The First Hospital of Jilin University, Changchun
Affiliated Hospital of Guangdong Medical University
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Guangdong 999 Brain Hospital
OTHER
The Second Hospital of Hebei Medical University
OTHER
Panjin Liaoyou Gem Flower Hospital
UNKNOWN
Wuxi People's Hospital
OTHER
Huizhou Third People's Hospital, Guangzhou Medical University
OTHER
The First Hospital of Jilin University
OTHER