Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastases From Non-small Cell Lung Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

March 1, 2017

Primary Completion Date

September 15, 2018

Study Completion Date

January 5, 2019

Conditions
Leptomeningeal Metastases
Interventions
DRUG

Pemetrexed

Pemetrexed,10-15 mg, intrathecal injection via lumbar puncture, twice per week for 2 weeks, followed by once per week for 2-4 weeks.

DRUG

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.

DRUG

Folic Acid

Folic acid, 400 μg, oral, once per day, prior to the first intrathecal pemetrexed, until 21 days after the last intrathecal pemetrexed.

DRUG

Vitamin B12

A single dose of vitamin B12 1000 μg, intramuscular injection, before the first intrathecal pemetrexed.

Trial Locations (1)

130021

The First Hospital of Jilin University, Changchun

All Listed Sponsors
lead

The First Hospital of Jilin University

OTHER

NCT03101579 - Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastases From Non-small Cell Lung Cancer | Biotech Hunter | Biotech Hunter