Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Meningeal Carcinomatosis

Meningeal Neoplasms

Meningitis

Neuroinflammatory Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Lymphosarcoma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Cytarabine

Methotrexate

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Antiviral Agents

Folinic Acid

Folate

Vitamin B9

Intrathecal (injected into the spinal fluid) DepoCyt

Intrathecal methotrexate

Intrathecal cytarabine (also known as ara-C)

Ahmet Tutuncu, MD, PhD

The purpose of this study is to find out how well an experimental drug called DepoCyt works for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine). Cytarabine has been used for many years to treat cancer.

DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor

A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis

Pacira Pharmaceuticals, Inc

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Breast Neoplasms

Neoplastic Processes

Hormones

Subjects with Breast Cancer of all subtypes and independent of Hormone status who have a confirmed or suspicious Leptomeningeal Metastasis by Investigator assessment of radiographic image and clinical evaluation and cytology

Subjects with Non-Small Cell Lung Cancer of all subtypes who have a confirmed or suspicious Leptomeningeal Metastasis by Investigator assessment of radiographic image and clinical evaluation and cytology

The Cerebro-Spinal Fluid (CSF) of subjects enrolled into each cohort will be used for Standard of Care diagnostic assessments used for subjects with either confirmed or suspicious LM (Cytology, protein and glucose) in combination with CNSide analysis.

CNSide

Priya Kumthekar, MD

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.

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). LM is a devastating complication of breast cancer and NSCLC and is diagnosed via clinical evaluation, MRI (with and without contrast of the brain and spine), and CSF Cytology. These methods have limited sensitivity and specificity. Furthermore, they lack the ability to quantitatively measure the LM's response to treatment. These hindrances create challenges for physicians to manage LM or to determine the best course of treatment. CNSide, is a Laboratory Developed Test (LDT ) that is analytically validated and run commercially in Biocept's CLIA certified, CAP accredited laboratory at the Physician's discretion. CNSide can detect and quantify tumor cells in the CSF from patients with Breast Cancer or NSCLC having a suspicious or confirmed LM. Data derived from case studies suggest that the detection of tumor cells in the CSF by CNSide can be used by Physicians to monitor the response of the LM tumor to treatment and improve the ability to make treatment decisions in patients with LM. Subjects enrolled onto the trial will be treated per Standard of Care. The diagnostic tests used to either diagnose LM, or monitor the LMs response to treatment will be Standard of Care, in combination with CNSide. The goal of the FORESEE Study is to further evaluate the performance of CNSide for LM in monitoring the LM's response to treatment and to assess the impact of CNSide on treatment decisions made by Physicians.

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

A Longitudinal Therapy Response Monitoring Study in Subjects With Leptomeningeal Metastases Using CNSide (CSF Tumor Cells) Compared to Standard of Care (CSF Cytology, Clinical Evaluation, and Imaging).

There is no plan to make the IDP available to other researchers.

The proportion of decision points during LM treatment in which the physician indicated that CNSide aided in their decision making.

The correlation of changes in tumor cell number throughout treatment with clinical evaluation, cytology, and radiographic results.

The comparison of the sensitivity, specificity, PPV and NPV of CNSide to cytology in detection of tumor cells in the CSF (Cytology being the reference standard)

ICON plc

Biocept, Inc.

Clinical neurological assessment performed by 2 raters

Neurological Assessment

Barbara O'Brien

Dieta Bransdma

Emilie Le Rhun

The goal of this project is to develop and validate a reproducible scorecard for the neurological assessment of patients with leptomeningeal metastases that can be used in clinical trials including such patients, as well as in clinical practice.

Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

M.D. Anderson Cancer Center

The Netherlands Cancer Institute

University of Zurich

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor	NCT00029523	Meningeal Neopl...	Intrathecal (in... Intrathecal met... Intrathecal cyt...	18 Years -	Pacira Pharmaceuticals, Inc
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide	NCT05414123	Leptomeningeal ... Leptomeningeal ... Leptomeningeal ... Breast Cancer Non-Small Cell ...	CNSide	-	Biocept, Inc.
Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis	NCT06417710	Leptomeningeal ... Leptomeningeal ... Leptomeningeal ... Leptomeningeal ...	Neurological As...	18 Years -	University of Zurich

Spots Global Cancer Trial Database for leptomeningeal neoplasms