Clinical trials: Leptomeningeal Metastasis, active
Leptomeningeal Metastasis, Breast Cancer
BRain-AVOidant Proton Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumor Malignancies
The purpose of this study is to determine the efficacy of BRain-AVOidant proton craniospinal irradiation (BRAVO pCSI) in adult participants with leptomeningeal metastases from solid tumors.
- Conditions
- Leptomeningeal Metastasis, Breast Cancer, Lung Cancer (NSCLC)
- Trial name
- BRAVO-LM (NCT07789912)
- Testing
- Radiation Treatments Using Brain- Avoidant Proton Craniospinal Irradiation (BRAVO- pCSI)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Miami
Leptomeningeal Metastasis
Immune Checkpoint Inhibitor Combined With Pemetrexed Intrathecal Injection for Leptomeningeal Metastasis From Solid Tumors
This is an open-label, single-arm, phase I/II trial of immune checkpoint inhibitor combined with pemetrexed intrathecal injection for leptomeningeal metastasis from solid tumors.
- Trial name
- NCT06462222
- Testing
- Toripalimab, pemetrexed
- Where
- 5 sites in China
- Volunteers
- 45 people
- Sponsor
- Guangzhou Medical University
EGFR Activating Mutation, Leptomeningeal Metastasis
CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer With Leptomeningeal Disease
Leptomeningeal disease is malignant seeding of the leptomeninges and presents with a variety of symptoms frequently impacting quality of life.
- Conditions
- EGFR Activating Mutation, Leptomeningeal Metastasis, Non Small Cell Lung Cancer
- Trial name
- NCT05257967
- Testing
- Lumbar puncture and Phlebotomy
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- British Columbia Cancer Agency
Leptomeningeal Metastasis
Intrathecal Combination of Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis
Leptomeningeal metastasis, characterized by tumor cells infiltrating and proliferating in the subarachnoid space, represents a distinct pattern of central nervous system involvement and is a fatal complication of malignant…
- Trial name
- NCT06762080
- Testing
- Cadonilimab (AK104), Pemetrexed (Alimta)
- Where
- 3 sites in China
- Volunteers
- 39 people
- Sponsor
- Guangzhou Medical University
Leptomeningeal Metastasis, Pemetrexed
Intrathecal Dual Checkpoint Inhibitor (PD-1 and CTLA-4) in Combination With Pemetrexed for Leptomeningeal Metastasis
This phase I/II study is to evaluate the recommended dose, safety, feasibility, and therapeutic response of intrathecal dual checkpoint inhibitor (targeting PD-1 and CTLA-4 with QL1706) in combination with pemetrexed in patients…
- Conditions
- Leptomeningeal Metastasis, Pemetrexed, PD-1 Inhibitor, CTLA4
- Trial name
- NCT06809530
- Testing
- QL1706 (bispecific antibody targeting PD-1 and CLTA-4), Pemetrexed (Alimta)
- Where
- 5 sites in China
- Volunteers
- 39 people
- Sponsor
- Guangzhou Medical University
Leptomeningeal Metastasis
Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases
This is an open-label, multicenter, Phase 1 study to determine the safety and efficacy of multiple doses at defined intervals of rhenium (186Re) obisbemeda (rhenium-186 nanoliposome, 186RNL) administered via intraventricular…
- Trial name
- CA2024-LM-001 (NCT07098806)
- Testing
- 186RNL
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Cerenome
Leptomeningeal Metastasis
Wearable-Triggered Digital Safety Net for Real-Time Monitoring & Intervention in Leptomeningeal Metastasis
This research study is for participants diagnosed with leptomeningeal metastasis disease (LMM), a condition where cancer has spread to the fluid and membranes surround the brain and spinal cord.
- Trial name
- NCT07704034
- Testing
- Calibration Phase, Stepped Wedge Intervention Phase
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Case Comprehensive Cancer Center
Breast Cancer, Quality of Life, Breast Cancer, Metastatic
Quality of Life for Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease
Central nervous system (CNS) metastases including breast cancer brain metastases (BCBMs) and leptomeningeal disease (LMD) are common affecting up to 30% of patients with metastatic breast cancer (MBC).
- Conditions
- Breast Cancer, Quality of Life, Breast Cancer, Metastatic, Breast Cancer, Metastatic Breast Cancer, Leptomeningeal Metastasis of Breast Cancer
- Trial name
- NCT07659652
- Testing
- Health-Related Quality of Life (QOL) questionnaires, Medical Chart Review
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of California, San Francisco
Leptomeningeal Metastasis
Thiotepa Administration Via Ommaya Reservoir for Leptomeningeal Metastases in Non-Small Cell Lung Cancer Resistant to EGFR-TKI.
The goal of this clinical trial is to learn if the Thiotepa administration via Ommaya Reservoir works to treat non-small cell lung cancer with leptomeningeal metastases resistant to EGFR TKI.
- Trial name
- LEP-THP-2026 (NCT07778940)
- Testing
- Thiotepa
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Leptomeningeal Metastasis From Lung Cancer
ctDNA-driven Adaptive Proton Craniospinal Irradiation in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis After Resistance to Third-Generation TKIs in the Consolidation Phase
Brief Summary (English) The goal of this clinical trial is to learn if a risk-adaptive consolidation therapy, guided by cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) clearance kinetics after induction intrathecal…
- Trial name
- NCT07751536
- Testing
- proton craniospinal irradiation, Intrathecal pemetrexed
- Where
- 3 sites in China
- Volunteers
- 84 people
- Sponsor
- Shuanghu Yuan
Leptomeningeal Metastasis From Lung Cancer
Amivantamab Combined With Intrathecal Pemetrexed for LM From EGFR-Mutated Lung Adenocarcinoma
The goal of this clinical trial is to learn whether amivantamab combined with intrathecal pemetrexed is safe and may help treat leptomeningeal metastasis in adults with EGFR-mutant lung adenocarcinoma.
- Trial name
- NCT07744529
- Testing
- Amivantamab+ systemic/ intrathecal Pemetrexed
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Leptomeningeal Metastasis of Breast Cancer
Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis
Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis
- Trial name
- NCT06543992
- Testing
- Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir
- Where
- China
- Volunteers
- 22 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
EGFR-TKI-resistant Non-small Cell Lung Cancer With Leptomeningeal Metastasis
Safety and Efficacy of Intrathecal Sacituzumab Tirumotecan for Leptomeningeal Metastasis in EGFR-TKI-Resistant Non-Small Cell Lung Cancer
This study is a Phase I, single-arm, single-center, dose-escalation clinical trial designed to investigate the safety and efficacy of intrathecal injection of sacituzumab tirumotecan (sac-TMT) in patients with EGFR…
- Trial name
- NCT07702305
- Testing
- Sacituzumab tirumotecan
- Volunteers
- 15 people
- Sponsor
- Henan Cancer Hospital
HER2-positive Breast Cancer, Leptomeningeal Metastasis
Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease
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…
- Conditions
- HER2-positive Breast Cancer, Leptomeningeal Metastasis, Leptomeningeal Disease
- Trial name
- NCT04588545
- Testing
- Radiation Therapy, Pertuzumab, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Solid Tumor, High-grade Glioma
Concurrent Azeliragon With Craniospinal Irradiation
Single institution study to assess the safety of concurrent Azeliragon with craniospinal irradiation (CSI) in patients with leptomeningeal metastasis from solid tumor malignancies and high-grade gliomas.
- Conditions
- Solid Tumor, High-grade Glioma, Leptomeningeal Metastasis
- Trial name
- NCT06724926
- Testing
- Azeliragon, CSI
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- NYU Langone Health
NSCLC, Low Dose Radiotherapy
Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer
This phase I study aims to investigate the safety and efficacy of whole brain low dose radiotherapy (WB-LDRT) combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer.
- Conditions
- NSCLC, Low Dose Radiotherapy, PD-1 Inhibitor, Leptomeningeal Metastasis
- Trial name
- NCT06431685
- Testing
- Whole Brain Low Dose Radiotherapy, Pemetrexed, Sintilimab
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Sichuan University
Leptomeningeal Metastasis From Lung Cancer
Exploration of the Application of Methotrexate-loaded Drug Vesicles in Intrathecal Injection for Meningeal Metastasis of Lung Cancer
This is a phase I/II, single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, and preliminary efficacy of intrathecal injection of methotrexate-loaded autologous tumor cell-derived…
- Trial name
- NCT07559097
- Testing
- Methotrexate-loaded vesicles
- Where
- China
- Volunteers
- 14 people
- Sponsor
- Henan Cancer Hospital
NSCLC (Non-small Cell Lung Carcinoma), Leptomeningeal Metastasis
Zorifertinib Plus Intra-Ommaya CSF Chemotherapy for Leptomeningeal Progression in NSCLC After Third-Generation EGFR-TKI
A Prospective Study of Zorifertinib Combined with Intra-Ommaya Reservoir Cerebrospinal Fluid Chemotherapy for Leptomeningeal Progression in NSCLC Patients After Third-Generation EGFR-TKI Therapy
- Conditions
- NSCLC (Non-small Cell Lung Carcinoma), Leptomeningeal Metastasis, EGFR-TKI Sensitizing Mutation, Zorifertinib
- Trial name
- NCT07551414
- Testing
- Zorifertinib Plus Intra-Ommaya CSF Chemotherapy
- Where
- China
- Volunteers
- 38 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Leptomeningeal Metastasis, Lung Neoplasms, Non-Small Cell Lung Cancer
Double-Dose Third-Generation EGFR-TKI Plus Bevacizumab and Intrathecal Chemotherapy for Refractory Leptomeningeal Metastatic NSCLC: A Phase II Study
The goal of this clinical trial is to explore the efficacy and safety of double-dose third-generation EGFR-TKI combined with bevacizumab and intrathecal chemotherapy in treating advanced non-small cell lung cancer (NSCLC)…
- Trial name
- NCT07398599
- Testing
- a combined regimen consisting of double-dose third-generation EGFR-TKI, bevacizumab, and intrathecal chemotherapy in patients
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Second Affiliated Hospital of Nanchang University
Brain Metastases, Leptomeningeal Metastasis
GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases
This study will test the safety of the study drug, GDC-0084, in combination with radiation therapy in people who have solid tumor brain metastases or leptomeningeal metastases.
- Trial name
- NCT04192981
- Testing
- GDC-0084, whole brain radiation therapy radiation
- Where
- 9 sites in United States
- Volunteers
- 21 people
- Sponsor
- Memorial Sloan Kettering Cancer Center