Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastases From

Status Completed

Clinical Trial Summary

It has been proved that intrathecal chemotherapy is the main treatment strategy for leptomeningeal metastases. At present, the commonly used drugs for intrathecal chemotherapy include methotrexate, cytarabine, and liposomal cytarabine. In recent decades, no new effective drugs have been discovered for intrathecal chemotherapy. The recurrence of leptomeningeal metastases is inevitable even after aggressive treatment. There is no effective treatment for recurrent leptomeningeal metastases after comprehensive treatment which includes intrathecal methotrexate and/or cytarabine, central nervous system radiation therapy, systemic chemotherapy as well as tyrosine-kinase inhibitor drugs. The quality of life is extremely poor, and the patients always die in short time. Pemetrexed is a newer multitargeted antifolate which has shown activity in various tumors. It has higher effectiveness and safety, which has been used as the first-line treatment of non-small cell lung cancer. In animal studies, pemetrexed was demonstrated to suppress tumor growth completely in mice with two types of transplanted human colon xenografts resistant to methotrexate. Therefore, the purpose of the study is to evaluate the safety and feasibility of intrathecal pemetrexed in patients with recurrent leptomeningeal metastases from non-small cell lung cancer.

Clinical Trial Description

This is a single arm clinical trial. The objective of the study is patients with recurrent or progressive leptomeningeal metastases from non-small cell lung cancer after leptomeningeal metastases-related treatment. The regimen of pemetrexed (Alimta, Eli Lilly and Company) is 10/15/20 mg, plus dexamethasone 5 mg, twice per week for 2 weeks, followed by once per week for 2-4 weeks. Pemetrexed and dexamethasone are administrated by intrathecal injection via lumbar puncture. Folic acid and vitamin B12 are administered to reduce the frequency of myelosuppression. Folic acid 200-400 μg is administered orally once daily, prior to the first intrathecal pemetrexed, until 21 days after the last intrathecal pemetrexed. A single dose of vitamin B12 1000 μg is administered by intramuscular injection before the first intrathecal pemetrexed，once per 3 weeks. To detect the pharmacokinetics of intrathecal pemetrexed, the serum and cerebrospinal fluid samples are collected. These samples would be analyzed by spectrometer for drug concentration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03101579
Study type	Interventional
Source	First Hospital of Jilin University
Contact
Status	Completed
Phase	Phase 1
Start date	March 1, 2017
Completion date	January 5, 2019

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT01438021` - Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease	N/A
Completed	`NCT02616393` - Phase 2 Study of Study of Tesevatinib in Subjects With NSCLC and Brain or Leptomeningeal Metastases	Phase 2
Not yet recruiting	`NCT06462092` - Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer	Phase 1/Phase 2
Active, not recruiting	`NCT03719768` - Avelumab With Radiotherapy in Patients With Leptomeningeal Disease	Phase 1
Terminated	`NCT00005812` - Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma	Phase 2
Terminated	`NCT03661424` - BATs in Patients With Breast Cancer and Leptomeningeal Metastases	Phase 1
Active, not recruiting	`NCT05289908` - Intrathecal Pemetrexed for Leptomeningeal Metastasis	Phase 1/Phase 2
Recruiting	`NCT05184816` - A Study of Deferoxamine (DFO) in People With Leptomeningeal Metastasis	Phase 1
Not yet recruiting	`NCT03613181` - ANG1005 in Leptomeningeal Disease From Breast Cancer	Phase 3
Terminated	`NCT03275402` - 131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases	Phase 2/Phase 3
Completed	`NCT01645839` - Interest of Intrathecal Chemotherapy With Liposomal Cytarabine (DepoCyte®) in Meningeal Metastasis of Breast Cancer	Phase 3
Completed	`NCT03520504` - Study of Proton Radiation to the Brain and Spinal Cord for Patients With Leptomeningeal Metastases	Phase 1
Completed	`NCT00992602` - Liposomal Cytarabine and High-Dose Methotrexate in Treating Patients With Central Nervous System Metastases From Breast Cancer	Phase 2
Completed	`NCT00005811` - Topotecan Hydrochloride in Treating Children With Meningeal Cancer That Has Not Responded to Previous Treatment	Phase 2
Active, not recruiting	`NCT04343573` - Proton Craniospinal Radiation Therapy vs. Partial Photon Radiation Therapy for Leptomeningeal Metastasis From Solid Tumors	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms