Intrathecal Pemetrexed for Leptomeningeal Metastasis
Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
Intrathecal chemotherapy is one of the most important treatment modalities for leptomeningeal
metastasis of solid tumors. In the previous study(Intrathecal Pemetrexed for Recurrent
Leptomeningeal Metastasis From Non-small Cell Lung Cancer: A Prospective Pilot Clinical
Trial. ClinicalTrials.gov identification number: NCT03101579), pemetrexed presented
feasibility of intrathecal administration. Pemetrexed at 10 mg dose level on the schedule of
1-2 times per week was recommended as an intrathecal administration agent for patients with
refractory leptomeningeal metastases from non-small-cell lung cancer in the previous study.
Moreover, the maximum-tolerated dose and recommended dose of intrathecal pemetrexed in the
previous study was obtained without vitamin supplementation. Vitamin supplementation has been
shown to reduce pemetrexed-induced myelosuppression. In this study, the regimen of
intrathecal pemetrexed with folic acid and vitamin B12 supplementation may provide higher
safety. Therefore, the purpose of this study is to investigate of maximally tolerated dose of
intrathecal pemetrexed with vitamin supplementation as the first-line treatment in patients
with leptomeningeal metastases from malignant solid tumors.
Phase:
Phase 1
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
Treatments:
Dexamethasone Folic Acid Hydroxocobalamin Pemetrexed Vitamin B 12