Neoplasms

Blood and Lymph Conditions

All Conditions

Nervous System Diseases

Leukemia

Central Nervous System Diseases

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.

Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.

Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.

Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I.

Intrathecal Rituximab

Elias Jabbour, MD

The goal of this clinical research study is to learn about the safety and effectiveness of rituximab given by spinal tap in patients with lymphoid malignancies involving the central nervous system.

A spinal tap (also called a lumbar puncture) is when fluid surrounding the spinal cord is collected by inserting a needle into the lower back. The affected area is numbed with local anesthetic during the procedure. It will also be used to give chemotherapy in this study.

Rituximab is designed to bind to a protein, called CD20, that is on the surface of the leukemia cells. This may cause the leukemia cells to die.

Study Groups and Study Drug Administration:

If you are found to be eligible, you will be assigned to a study group based on when you join this study. Up to 12 participants will be enrolled in the Phase I portion of the study, and up to 13 participants will be enrolled in Phase II.

If you are enrolled in the Phase I portion, the dose of rituximab you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of rituximab. Each new group will receive a higher dose of rituximab than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of rituximab is found.

If you are enrolled in the Phase II portion, you will receive rituximab at the highest dose that was tolerated in the Phase I portion.

Study Visits:

Once enrolled, you will return to the clinic and receive the study drug by spinal tap up to 2 times a week. You will receive treatment twice a week until 2 CSF samples in a row do not show any leukemia cells. After that, you will receive treatment 1 time a week for an additional 4 weeks, and then you will receive treatment once every other week for an additional 8 weeks. The number of doses you receive will depend on how many doses the study doctor thinks is needed.

At each study visit the following procedures will be performed:

* You will have a physical exam, including measurement of your weight, and vital signs. °Your vital signs will be measured every 15 minutes for 1 hour after each dose of rituximab.
* You will be asked how well you are able to perform the normal activities of daily living (performance status).
* You will be asked about any drugs you may be taking and any side effects you may experiencing.
* Blood (about 2 tablespoons) will be drawn for routine tests.
* A sample of cerebral spinal fluid may be collected from the lumbar puncture to verify the absence or presence of blast cells.

Follow-Up:

About 30 days after your last dose of study drug you will be contacted by the study staff by telephone and asked about any drugs you may be taking and any side effects you may experiencing. This call should take about 10 minutes.

Long-term Follow-up:

Every 6 to 12 months you may be contacted by the study staff by telephone and asked about any drugs you may be taking and any side effects you may experiencing. This call should take about 10 minutes.

You may be given other drugs to help prevent side effects. The study staff will tell you about these drugs, how they will be given, and the possible risks.

Length of Treatment:

The number of treatments you receive will depend on how long it takes for there to be no leukemia cells in the CSF samples. Once this happens, you will have treatments for an additional 12 weeks. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study. Rituximab is FDA approved and commercially available for the treatment of relapsed and/or refractory lymphoid malignancies involving the central nervous system. Receiving rituximab by spinal tap is considered investigational.

Up to 25 patients will take part in this study. All will be enrolled at MD Anderson.

Intrathecal Rituximab in Lymphoid Malignancies Involving Central Nervous System

Safety and Efficacy of Intrathecal Rituximab in Patients With Lymphoid Malignancies Involving the Central Nervous System

The percentage of participants whose cancer shrinks or disappears after treatment where participants are considered as responding to therapy if the Cerebrospinal fluid (CSF) is without evidence of blast cells after four lumbar punctures with rituximab.

MTD is dose level at which at least 1 of 3 participants experiences a dose-limiting toxicity (DLT). DLTdefined as clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meeting the NCI common terminology criteria that are CTCAE Grade 3 or 4.

M.D. Anderson Cancer Center

Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.

Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.

Intrathecal Rituximab: Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.

Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Elias Jabbour MD/Associate Professor

Response Rate

Multiple dose levels were designed with a starting dose of 10 mg per injection followed by 25 mg once safety was established in the first 3 patients treated at the first dose level. The study moved tot he next dose level. Due to lack of response and slow accrual, participants were never treated on the next dose level and the study was terminated

Maximum Tolerated Dose (MTD) of Rituximab

Overall Study

Immune System Diseases

Rare Diseases

Hypersensitivity

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Primary Central Nervous System Lymphoma

Patients (pts) with clinical and radiological suspicion of PCNSL or with confirmed diagnosis of PCNSL will be enrolled to the protocol. They will represent the "Study population"

1. Pts with suspicion of secondary CNS lymphoma, that includes subjects with DLBCL and involvement of the CNS at presentation in association with systemic disease, or subjects with systemic DLBCL and CNS relapse during or after primary therapy.
2. Pts with histological diagnosis of systemic DLBCL at high risk of CNS relapse according to Institutional guidelines and patients with histological diagnosis of systemic high grade B cell lymphoma, according to 2017 WHO classification;
3. pts affected by neurological disorders that are usually differential diagnosis of PCNSL (i.e. neurodegenerative and neuroinflammatory disorders, toxic or infective encephalitis, other primary CNS tumors).

A lumbar puncture (spinal tap) is performed in patient lower back, in the lumbar region.

During a lumbar puncture, a needle is inserted between two lumbar bones (vertebrae) to remove a sample of cerebrospinal fluid (CSF). This is the fluid that surrounds brain and spinal cord to protect them from injury.

This procedure is usually performed at the time of diagnosis for disease staging and/or repeated in the course of the disease history, only if positive or for clinical reasons (i.e. suspicious of relapse progression).

In this study sequential CSF and peripheral blood samples of study population will be collected also at different time points, with the aim to improve diagnostics sensitivity, response assessment and monitoring early CNS relapse.

Lumbar puncture

Andrés J.M. Ferreri, MD

Teresa Calimeri, MD/PhD

Sara Steffanoni, MD

Thi is a prospective and low-intervention clinical trial. We propose to design a panel of "core" genetic alterations by sequencing Cerebral Spinal Fluid (CSF) DNA in patients with confirmed or suspicious Primary Central Neurvous System Lymphoma (PCNSL) with the aim to improve diagnostic sensitivity, response assessment and monitoring early CNS relapse in routine practice.

Enrolled patients will receive conventional treatments according to well-established international guidelines, DNA assessments will not influence the treatment choices.

Diagnosis; Objective RespOnse; THErApy

Mutational Analysis in the Cerebrospinal Fluid to Improve Diagnostic Sensitivity, Response Definition and Precision Treatment in Primary Central Nervous System Lymphoma

Frequency of various genetic mutations among enrolled patients at diagnosis or relapse

Frequency of various genetic mutations among enrolled patients during treatment

Teresa Calimeri

Sara Steffanoni

IRCCS San Raffaele

Principal Investigator; Lymphoma Unit, Head

Symptoms and General Pathology

Meningeal Carcinomatosis

Meningeal Neoplasms

Meningitis

Neuroinflammatory Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Anti-Infective Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Cytarabine

Methotrexate

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

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

Brain Diseases

Brain Neoplasms

Antibodies

Antibodies, Monoclonal

Bevacizumab

Immunoglobulins

Angiogenesis Inhibitors

Growth Inhibitors

Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.

10 mg/kg by vein over about 1 hour, every 2 weeks.

Ivo D. Tremont, MD

The goal of this clinical research study is to learn if and how Avastin (bevacizumab) may affect cancer that has spread to the meninges of the brain or the spinal cord. The safety of this drug will also be studied.

Objectives:

1. Primary:

1. Determine preliminary response data of intravenous bevacizumab in patients with NM

a. As measured by clearance of malignant cells from the Cerebrospinal fluid (CSF) at 2, 4, 6, 12, 18, and 24 weeks, then every 8 weeks up to 54 weeks, and

b. Time to neurological progression (TTNP)

2. Secondary:

1. Evaluate the safety of intravenous bevacizumab in patients with NM
2. Further describe the efficacy of this intervention as measured by

   1. improvement of MR imaging evidence of disease
   2. overall survival
   3. maintenance of quality of life
3. Determine effects of systemically administered bevacizumab on CSF, serum, and urine Vascular endothelial growth factor (VEGF)levels levels
4. Correlate changes in CSF VEGF with response measurements.
5. Correlate primary tumor tissue VEGF expression with CSF VEGF levels
6. Correlate urine VEGF levels with serum and CSF VEGF levels
7. Evaluate serum and CSF VEGF index

The Study Drug:

Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.

Study Drug Administration:

If you are found to be eligible to take part in this study, every 2 weeks, you will receive bevacizumab by vein over about 1 hour.

Study Visits:

At Weeks 2 and 4:

* Samples of CSF from your spinal cord will be collected to check for the presence of cancer cells.
* Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.
* If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
* You will be asked about any drugs you may be taking and if you have experienced any side effects.
* You will have a neurological exam.

At Weeks 6, 12, 18, and 24, and then every 8 weeks:

* Samples of CSF from your spinal cord will be collected to check for the presence of cancer cells.
* Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.
* If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
* You will have a physical exam (Weeks .
* Your performance status will be recorded.
* You will be asked about any drugs you may be taking and if you have experienced any side effects.
* You will have a neurological exam.
* You will complete the questionnaire about your quality of life.
* You will have an MRI scan to check the status of the disease.
* Urine will be collected to test kidney function and for routine tests. If indicated urine will be collected over a 24 hour period.

Every 2 weeks, your blood pressure will be measured.

Length of Study:

You will be on study for up to 54 weeks (about 1 year). You will be taken off study early if the disease gets worse or you experience intolerable side effects.

End-of-Study Visit:

If you go off study early, the following tests and procedures will be performed:

* You will have a physical exam.
* Your performance status will be recorded.
* You will have a neurological exam.
* Samples of CSF from your spinal cord will be collected to look for the presence of cancer cells.
* Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally. You will complete the questionnaire about your quality of life.
* If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.

Follow-up Visits:

If you do not go off study early, within 4 weeks after the last dose of study drug, every 4 weeks for 3 months, and then every 3 months from then on, you will have follow-up visits. The following tests and procedures will be performed:

* You will have a physical exam.
* Your performance status will be recorded.
* You will have a neurological exam.
* Samples of CSF from your spinal will be collected to look for the presence of cancer cells.
* Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.

You will have an MRI scan to check the status of the disease.

-If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.

This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of colon, breast, and lung cancer. Its use for the treatment of cancer that has spread to the meninges of the brain or the spinal cord is investigational.

Up to 25 patients will take part in this study. All will be enrolled at MD Anderson.

A Pilot Study of Bevacizumab for Neoplastic Meningitis

A Pilot Study of Systemically Administered Bevacizumab in Patients With Neoplastic Meningitis (NM)

Neoplastic meningitis is considered an unmeasurable metastatic site by Response Evaluation Criteria in Solid Tumors (RECIST), and as such no standardized methodologies are routinely used; therefore response assessed from cerebrospinal fluid (CSF) obtained via lumbar puncture (and from ventricular reservoir if present) and analyzed for malignant cells along with reference recording of magnetic resonance imaging (MRI) of areas of enhancement over time; however, MRI alone in LMD/NM is considered non-evaluable by RECIST criteria. Those participants with only MRI criteria for enrollment, but who later develop CSF positivity after enrollment were declared "progressors" based on the CSF criteria.

CSF response for participants with Neoplastic Meningitis (NM) or leptomeningeal disease (LMD) defined as conversion from positive to negative cytology or cytometry as measured routinely by total clearance of malignant cells from the CSF where assessments performed from 2 weeks up to week 54 of treatment. Clearance of malignant cells determined by standard clinical testing using cytospin analysis in clinical laboratory. Percentage reflects number of participants of total treated with no response, e.g. participants with continued positive CSF cytology or flow cytometry.

Time to Progression defined as time to disease progression measured from date of enrollment, confirmation of disease progression via laboratory testing; Time to neurological progression (TTNP) reflects worsening clinical signs/symptoms or development of new clinical signs/symptoms which investigator feels can be attributed to leptomeningeal disease progression and are severe enough to warrant a change in therapy.

Genentech, Inc.

Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.

United States

Region of Enrollment

John F de Groot, Professor, Neuro-Oncology

Of the 20 registered, 5 were screening failures therefore are not included in the analysis.

Cerebrospinal Fluid (CSF) Response Rate: Percentage of Participants Positive for Tumor Cells

TTNP

Median Time to Progression (TTP) and Median Time to Neurological Progression (TTNP)

No Change/Stable Disease (SD)

Progressive Disease (PD)

Complete Remission (CR)

Participant Response: Cerebrospinal Fluid (CSF) Examination

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intrathecal Rituximab in Lymphoid Malignancies Involving Central Nervous System	NCT01596127	Leukemia Lymphoid Malign... Metastatic Mali...	Intrathecal Rit...	3 Years -	M.D. Anderson Cancer Center
Diagnosis; Objective RespOnse; THErApy	NCT05036564	Primary CNS Lym...	Lumbar puncture	18 Years -	IRCCS San Raffaele
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 Pilot Study of Bevacizumab for Neoplastic Meningitis	NCT00924820	Neoplastic Meni...	Bevacizumab	18 Years -	M.D. Anderson Cancer Center
Diagnosis; Objective RespOnse; THErApy	NCT05036564	Primary CNS Lym...	Lumbar puncture	18 Years -	IRCCS San Raffaele

Spots Global Cancer Trial Database for csf

Every month we try and update this database with for csf cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for csf

Every month we try and update this database with for csf cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for csf cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.