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Leptomeningeal Disease clinical trials

View clinical trials related to Leptomeningeal Disease.

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NCT ID: NCT06146010 Not yet recruiting - Clinical trials for Leptomeningeal Disease

Non Interventional German Leptomeningeal Disease Register

Start date: January 2024
Phase:
Study type: Observational [Patient Registry]

The planned multicenter register is intended to create a database in the form of a cancer register on the incidence and course of disease in Germany of leptomeningeal disease, the therapeutic measures administered in the real world and the complications.

NCT ID: NCT05809752 Recruiting - Clinical trials for Triple Negative Breast Cancer

A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV)

Start date: August 22, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn about the effects of the study treatment, Dendritic Cell Vaccine (DCV), to find the highest dose of the study treatment that can be given safely to Breast Cancer patients with Leptomeningeal Disease

NCT ID: NCT05800275 Recruiting - Clinical trials for Leptomeningeal Metastasis

Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease

ETIC-LM
Start date: December 18, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy of tucatinib and capecitabine in combination with intrathecal trastuzumab on overall survival rate at 12 months in HER2-positive metastatic breast cancer (MBC) patients with proven leptomeningeal evolution and requiring intrathecal therapy.

NCT ID: NCT05414123 Terminated - Breast Cancer Clinical Trials

A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide

FORESEE
Start date: September 7, 2022
Phase:
Study type: Observational

The FORESEE Study is a multi-center, prospective clinical trial enrolling patients with Breast or Non-Small Cell Lung Cancer (NSCLC) who have suspicious or confirmed Leptomeningeal Metastases (LM). Standard of Care methods to diagnose, or assess the treatment response of LM (Clinical Evaluation, MRI and Cytology) have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. CNSide, is a Laboratory Developed Test (LDT ) that is used commercially at the Physician's discretion in Biocept's CLIA certified, CAP accredited laboratory. CNSide can detect and quantify tumor cells in the CSF from patients with Breast Cancer or NSCLC having a suspicious or confirmed LM. The goal of the FORESEE Study is to evaluate the performance of CNSide in monitoring the LM's response to treatment and to assess the impact of CNSide on treatment decisions made by Physicians.

NCT ID: NCT05112549 Recruiting - Clinical trials for Leptomeningeal Disease

Intrathecal Application of PD1 Antibody in Metastatic Solid Tumors With Leptomeningeal Disease (IT-PD1/ NOA 26)

IT-PD1
Start date: October 12, 2021
Phase: Phase 1
Study type: Interventional

To determine the safety of intrathecal (IT) PD1 antibody for Intrathecal application of PD1 antibody in metastatic solid tumors with leptomeningeal disease of solid tumors.

NCT ID: NCT04588545 Recruiting - Clinical trials for HER2-positive Breast Cancer

Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease

Start date: December 10, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to find out if radiation therapy followed by intrathecal trastuzumab and pertuzumab is safe and will result in improved survival in HER2 positive breast cancer which has metastasized to the leptomeninges.

NCT ID: NCT03719768 Active, not recruiting - Clinical trials for Leptomeningeal Metastases

Avelumab With Radiotherapy in Patients With Leptomeningeal Disease

Start date: June 10, 2019
Phase: Phase 1
Study type: Interventional

This study is to find a safe dose of the combination of Avelumab and Whole Brain Radiotherapy (WBRT) in patients with Leptomeningeal Disease.

NCT ID: NCT03711422 Terminated - Clinical trials for Non-small Cell Lung Cancer

Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC

Start date: November 16, 2018
Phase: Phase 1
Study type: Interventional

Brain metastases occurs in up to 50% of patients with EGFR mutant NSCLC. Leptomeningeal disease is a subset of patients with brain metastases for which there remains an unmet need. This trial aims to evaluate the role of two dosing schedules of afatinib in management of leptomeningeal disease in EGFR mutant NSCLC, specifically to determine Central Nervous System (CNS) penetration of afatinib, as well as clinical activity. Patients will start on daily dosing initially followed by pulsed intermittent dosing should we observe no clinical activity. A secondary objective is to identify the resistance spectrum in leptomeningeal disease. It is anticipated that optimal dosing schedule of afatinib e.g. pulsed dosing may improve CNS disease control.

NCT ID: NCT03501979 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD

Start date: February 20, 2019
Phase: Phase 2
Study type: Interventional

A phase 2 non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab with capecitabine for the treatment of leptomeningeal metastases in HER2-neu positive breast cancer.

NCT ID: NCT02422641 Recruiting - Clinical trials for Metastatic Breast Cancer

Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis

Start date: May 2015
Phase: Phase 2
Study type: Interventional

Management of leptomeningeal disease (LMD) in patients with metastatic breast cancer is an area of unmet clinical need. High-dose methotrexate (HD-MTX) is known to have activity against breast cancer and in contrast to other systemic chemotherapeutics, it penetrates the blood brain barrier, targets areas of poor cerebrospinal fluid flow, may penetrate bulky leptomeningeal disease, and provide treatment to systemic disease burden. While two retrospective studies have suggested activity of HD-MTX in LMD in patients with breast cancer, no prospective data are available to inform its inclusion in treatment regimens. Thus, while HD-MTX is included in the NCCN Guidelines for LMD and while it is used to varying degrees in cancer centers across the nation, this is more representative of the lack of available therapies for LMD as opposed to strong evidence-based data. This phase II, prospective study will evaluate systemic, intravenous HD-MTX in breast cancer patients with leptomeningeal metastasis with or without brain parenchymal metastasis.