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Clinical Trials

Clinical trials are research studies that test how diseases can be detected, prevented or treated. They can also study quality of life by looking at how patients feel from a disease and how they feel from the treatment.

For leptomeningeal cancer, clinical trials test new and existing treatments. These treatments may be medications, surgery, radiation, or other methods. 

Scientists design trials to answer questions about:

  • Safe doses
  • Ways to deliver treatment
  • Side effects
  • Effectiveness 
  • Length of life

 

Clinical trials take place in phases:

  • Phase 1 trials test a treatment for safety and side effects in a small group of people. 
  • Phase 2 trials further study safety and determine how effective treatments are in a larger group of people.
  • Phase 3 trials compare the new treatment with standard or similar treatments to confirm its effectiveness and monitor side effects. The trials also collect other important information about the new treatment. These trials test treatments in a large group of people.

 

Items to note:

  • Many trials have a set number of people they can admit into a trial. 
  • Each trial has a list of inclusion and exclusion criteria. These are factors required for someone to be included or factors that prevent someone from being in the trial. This could be your physical condition, the status of your disease, or prior treatments.
  • Clinical trials may only be available in certain places. You may need to travel to be in a trial.
  • Most trials studying leptomeningeal cancer are Phase 1, some are Phase 2. There are no current Phase 3 trials.

Please read before proceeding:

  • The trials below are recruiting as of March 2026. This means the study is currently recruiting patients.
  • The information here is adapted from ClinicalTrials.gov for easy reviewing.
  • These trials are subject to change. We will do our best to update regularly to reflect any changes.
  • Inclusion and exclusion criteria are not included. We have just provided a general idea of who the trial is for. Please read the trial description at the link for more details.
  • If any of these trials are of interest, please visit the links for more information about the trials and reach out to the contacts listed.
  • Leptomeningeal Cancer Foundation does not recommend or take a position on any of the clinical trials listed on this page.
  • Leptomeningeal Cancer Foundation is not responsible for any errors, changes to trials or any misinformation.
  • Please consult with your doctor regarding clinical trials and which trial(s) may be appropriate for your individual case. 

CLINICAL TRIALS in the UNITED STATES

Trial #: NCT04588545

Locations:

  • Tampa, Florida
  • Evanston, Illinois
Clinical Trials.gov

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

Goal of study:

To find out if radiation therapy followed by intrathecal trastuzumab and pertuzumab is safe and will improve survival in patients with HER2 positive breast cancer with leptomeningeal metastasis.

Who this is for:

  • People 18 years and older
  • Patients with HER2+ cancers with leptomeningeal metastasis / LMD

Contacts:

Moffitt Cancer Center, Tampa, FL

Northwestern University, Evanston, IL

Trial #: NCT05184816

Locations:

  • New Jersey (Basking Ridge, Middletown, Montvale)
  • New York (Commack, Harrison, NYC, Uniondale)
Clinical Trials.gov

A Study of Deferoxamine (DFO) in People with Leptomeningeal Metastasis

Goal of study:

To find out if deferoxamine given intrathecally (directly into the CSF) is a safe treatment for people with leptomeningeal metastasis from solid tumor cancer.

Who this is for:

  • People 18 years and older
  • Patients with leptomeningeal metastasis from any solid tumor

Contacts:

Memorial Sloan Kettering Cancer Center, New York, NY

Trial #: NCT02422641

Locations:

  • Baltimore, Maryland
  • Winston-Salem, North Carolina
  • St Louis, Missouri
    (active, but not recruiting)
Clinical Trials.gov

Prospective Evaluation of High-Dose Systemic Methotrexate in Patients with Breast Cancer and Leptomeningeal Metastasis

Goal of study:

To determine if treatment with IV methotrexate will increase survival among patients with triple negative, HER2-positive, and hormone refractory metastatic breast cancer patients with LMD.

Who this is for:

  • People 18 years and older
  • Patients with invasive breast cancer – triple negative (TNBC), HER2+, and hormone refractory (ER/PR+)

Contacts:

Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, NC

Trial #: NCT05809752

Locations:

  • Tampa, Florida
Clinical Trials.gov

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

Goal of study:

To learn about the effects of Dendritic Cell Vaccine (DCV), and to find the highest dose of DCV that can be given safely to breast cancer patients with leptomeningeal disease.

Who this is for:

  • People 18 years and older
  • Patients with triple negative breast cancer (TNBC) or HER2+ breast cancer with leptomeningeal metastasis

Contacts:

Moffitt Cancer Center, Tampa, FL

Trial #: NCT06724926

Locations: New York, New York

Clinical Trials.gov

Concurrent Azeliragon with Craniospinal Irradiation

Goal of study:

To assess the safety of Azeliragon with radiation of the brain and spine in patients with leptomeningeal metastasis from solid tumor cancers and high-grade gliomas.

Who this is for:

  • People 18 years and older
  • Patients with solid tumors or high-grade gliomas and leptomeningeal metastasis


Contacts:

NY Langone Health, New York, NY

Trial #: NCT05746325

Locations: Jacksonville, Florida

Clinical Trials.gov

Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients with Breast or Lung Cancer

Goal of study

To evaluate the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung cancer.

Who this is for:

  • People 18 years and older
  • Patients with breast cancer and leptomeningeal metastases
  • Patients with lung cancer and leptomeningeal metastases

Contacts:

Mayo Clinic, Florida

Trial #: NCT06058988

Locations: New York, New York

Clinical Trials.gov

Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer

Goal of study:

To find out how much tratuzumab deruxtecan (T-DXd) can penetrate the tumor when injected into the body, and whether T-DXd may be an effective treatment for brain cancers that express the HER2 protein.

Who this is for:

  • People 18 years and older
  • Patients with a brain tumor that needs resection/biopsy and leptomeningeal metastasis may be eligible

Contacts:

Memorial Sloan Kettering Cancer Center, New York, NY

Trial #: NCT06518057

Locations: Seattle, Washington’ San Francisco (Not yet recruiting)

Clinical Trials.gov

Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases from Breast Cancer or Non-small Cell Lung Cancer

Goal of study:

To see how well radiation using proton therapy or volumetric modulated arc therapy (VMAT) with hippocampal avoidance works in patients with breast cancer or non-small cell lung cancer (NSCLC) with leptomeningeal metastases. Hippocampal avoidance reduces the amount of radiation to the hippocampus, which can reduce neurologic side effects from treatment.  

Who this is for:

  • People 18 years and older
  • Patients with breast cancer or non-small cell lung cancer (NSCLC) and leptomeningeal metastasis

Contacts:

Fred Hutch/University of Washington Cancer Consortium, Seattle, WA

Trial #: NCT06500481

Locations:

  • Multiple locations across the U.S. See ClinicalTrials.Gov for specific details.
Clinical Trials.gov

Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial

Goal of study:

To compare proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer with leptomeningeal metastasis

Who this is for:

  • People 18 years and older
  • Patients with breast cancer or non-small cell lung cancer (NSCLC) and leptomeningeal metastasis

Contacts:

Multiple locations across the U.S. See ClinicalTrials.Gov for specific details.

Trial #: NCT03684980

Locations:

  • Birmingham, Alabama (not recruiting)
  • Boston, Massachusetts (not recruiting)
  • New Jersey (Basking Ridge, Middletown, Montvale)
  • New York (Commack, Harrison, New York, Uniondale)
  • Ohio (Cleveland – recruiting; Cincinnati – not yet recruiting)
Clinical Trials.gov

LTA Pilot Study of Glucarpidase in Patients with Central Nervous System (CNS) Lymphoma

Goal of study:

To test the effects of Voraxaze (Glucarpidase) given in combination with methotrexate and rituximab, the standard treatment for CNS lymphoma.

Who this is for:

  • People 18 years and older
  • Patients with B-cell non-Hodgkin’s lymphoma involving the brain, spinal cord and/or leptomeningeal metastasis

Contacts:

Memorial Sloan Kettering Cancer Centers in NJ and NY


Cleveland Clinic, Cleveland, OH

  • Mina Lobbous
    Phone: 216.445.3307

Trial #: NCT06910761

Locations:

  • Duarte, California
  • Irvine, California
Clinical Trials.gov

Photon Craniospinal Irradiation for the Treatment of  Leptomeningeal  Disease  Secondary to Breast Cancer or Non-small Cell Lung Cancer

Goal of study:

To test how well photon craniospinal radiation works in patients with leptomeningeal metastasis from breast or non-small cell lung cancers

Who this is for:

  • People 18 years and older
  • Patients with breast cancer or non-small cell lung cancer (NSCLC) with leptomeningeal metastasis

Contacts:

City of Hope, California

 

Trial #: NCT07098806

Locations: San Antonio, TX

Clinical Trials.gov

Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases (CA2024-LM-001)

Goal of study:

To determine the safety and efficacy of multiple doses at defined intervals of rhenium (186Re) obisbemeda (rhenium-186 nanoliposome, 186RNL) given through an Ommaya port to identify a safe dose amount, dosing schedule, and number of doses. This is a Phase 1 study.

Who this is for:

  • People 18 years and older
  • Patients with any primary solid tumor cancer with leptomeningeal metastases

 

Study Contacts:

The Cancer Therapy and Research Center at UTHSCA

 

NOT YET RECRUITING as of February 2026

Trial #: NCT06984523

Locations:

  • New York, NY
Clinical Trials.gov

Study of Craniospinal Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients With Leptomeningeal Metastasis

This study is not yet recruiting participants.

Goal of study:

To confirm the safety and efficacy of linac based Volumetric Modulated Arc Therapy (VMAT) for radiation therapy in solid tumor cancer patients with leptomeningeal metastasis.

Who this is for:

  • People 18 years and older
  • Patients with any solid tumor cancer with leptomeningeal metastasis
  • Candidate for radiation therapy for the treatment of leptomeningeal metastases

Contacts:

NYU Langone Health, New York, NY

 

Trial #: NCT07199413

Locations:

  • Milwaukee WI
Clinical Trials.gov

A Phase I Pilot Safety and Feasibility Study for Solid Tumor Patients With CNS Metastases

This study is not yet recruiting participants.

Goal of study:

To evaluate the safety and feasibility of giving SV-BR-1-GM with pembrolizumab to patients who have solid tumor cancer with central nervous system metastases (brain metastases or leptomeningeal metastases)

Who this is for:

  • People 18 years and older
  • Patients with any solid tumor cancer with leptomeningeal metastasis and disease progression after 1 or more treatments

Contacts:

Medical College of Wisconsin Cancer Center Clinical Trials Office

 

Trial #: NCT07414979

Locations:

  • Houston, TX
Clinical Trials.gov

Phase 1 Study Of Intrathecal Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells For Patients With Leptomeningeal Melanoma

This study is not yet recruiting participants.

Goal of study:

The proposed Phase I trial is aimed at treating up to 6  individuals with leptomeningeal disease from metastatic melanoma who are HLA-A*0201+ and HLA-A*24 02+. The study will evaluate the safety of adoptively transferred intrathecal endogenous T cell (ETC) therapy and overall survival.

Who this is for:

  • People 18 years and older
  • Patients with confirmed diagnosis of LMD
  • Patients with a a confirmed diagnosis of primary CNS melanoma, melanocytomas or metastatic melanoma 
  • Expression of HLA-A2 or HLA-A24

Contacts:

The University of Texas M.D. Anderson Cancer Center

Trial #: NCT07390539

Locations:

  • Boston, MA
Clinical Trials.gov

B7-H3.CD28Z.CART in CNS Neoplasms

This study is not yet recruiting participants.

Goal of study:

The purpose of this study is to test the safety and effectiveness of a cell therapy at different doses for children and young adults with recurrent or progressive brain tumors.  This cell therapy is called B7- H3.CD28Z.CART, referred to as B7-H3 CAR T cells. B7-H3 is a protein that is over-expressed on many tumor cells, making it a good target for cancer cell therapy.

Who this is for:

  • Children and young adults 2 years to 21 years 
  • Please see the ClinicalTrials.gov page for specific criteria


Contacts:

Boston Children’s Hospital / Dana-Farber Cancer Institute

CLINICAL TRIALS in CANADA

Trial #: NCT06016387

Locations:

Canada (Ottawa, Toronto)

Clinical Trials.gov

Tucatinib With Brain and/or Spinal XRT in Patients With HER2+ Metastatic Breast Cancer and LMD

Goal of study:

To test the safety and efficacy of radiation therapy followed by systemic therapy among patients with HER2+ metastatic breast cancer and LMD

Who this is for:

  • People 18 years and older
  • Men or women with HER2+ metastatic breast cancer.
  • Evidence of LMD in the brain and/or spine

Contacts:

The Ottawa Hospital, Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

CLINICAL TRIALS in EUROPE

 

Trial #: NCT05746754

Locations:

  • Aalborg, Denmark
  • Aarhus, Denmark
Clinical Trials.gov

Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis (CSI ProLong)

Goal of study:

To test the effects of proton craniospinal radiotherapy, believed to offer superior survival and CNS control compared to focal photon radiotherapy.

Who this is for:

  • People 18 years and older
  • Patients with leptomeningeal metastasis from solid or hematological cancers

Contacts:

Aalborg University Hospital

  • Weronoka Szejniuk, MD

 

Aarhus University Hospital

 

Trial #: NCT05112549

Locations:

Germany (Bonn, Freiburg, Heidelberg, Heilbronn, Mannheim, München, Stuttgart, Tübingen, Ulm)

Clinical Trials.gov

Intrathecal Application of PD1 Antibody in Metastatic Solid Tumors With Leptomeningeal Disease

Goal of study:

To determine the safety of intrathecal PD1 antibody (Nivolumab) in metastatic solid tumors with leptomeningeal disease.

Who this is for:

  • People 18 years and older
  • Patients with LMD from a solid tumor

Contact:

Trial #: NCT05800275

Locations:

France (Bordeaux, Caen, Clermont-Ferrand, Dijon, Lyon,  Montpellier, Nice, Reims, Rouen, Strasbourg, Villejuif)

Clinical Trials.gov

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

Goal of study:

To test the efficacy of tucatinib and capecitabine in combination with intrathecal trastuzumab on overall survival rate in HER2-positive metastatic breast cancer patients with  leptomeningeal disease.

Who this is for:

  • People 18 years and older
  • Patients with HER2+ metastatic breast cancer and leptomeningeal cancer

Contacts:

 

Trial #: NCT06933199

Locations:

Czechia (Brno, Hradec Králové, Olomouc); Moravian-Silesian Region (Ostrava)

Clinical Trials.gov

Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis (NeoSTROBE)

Goal of study:

To establish the value of fractionated neoadjuvant stereotactic radiotherapy as a new treatment paradigm for brain metastases. 

Who this is for:

  • People 18 years and older
  • Target metastases indicated for surgical resection.
  • No history of whole brain radiation or stereotactic radiation to a brain metastasis
  • No cases of small cell lung cancer

Contacts: