ACTR-65. INTRATHECAL PEMETREXED FOR PATIENTS WITH RECURRENT LEPTOMENINGEAL METASTASIS FROM LUNG ADENOCARCINOMA: A PHASE I CLINICAL TRIAL (IPRLM,NCT03101579)

ABSTRACT: Abstract

BACKGROUND

To determine toxicities, maximally tolerated dose (MTD), and potential antitumor activity of intrathecal pemetrexed (IP). MATERIAL AND

METHODS

Pulmonary adenocarcinoma patients with recurrent or progressive leptomeningeal metastases (LM) after intrathecal chemotherapy and other LM-related therapy were included. IP doses escalated from 10 mg to 15 mg, and even 20 mg. Protocol schema of IP was twice per week for 2 weeks (induction therapy), followed by once per week for 2–4 weeks (consolidation therapy). The primary endpoints were MTD and safety. The secondary endpoint was efficacy. Plasma and cerebrospinal fluid (CSF) samples were collected and analyzed for drug concentration.

RESULTS

Nine patients (male: 3; female: 6; age: 37–71 years; median:

SUBMITTER: Pan Z 

PROVIDER: S-EPMC6216481 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature