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Nervous System Neoplasms

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Methotrexate

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3 consecutive cycles of intraventricular methotrexate infusions into implanted fourth ventricle catheter/Ommaya reservoir following surgical catheter placement into fourth ventricle, each cycle will be of 4 weeks duration. During the first 3 weeks, methotrexate will be infused twice weekly on days 1 and 4 (+/- 2 days). The 4th week is a rest week.

Surgical catheter placement into the fourth ventricle of the brain

Ommaya Reservoir

4, 6, or 8 mg into fourth ventricle of the brain via the Ommaya Reservoir for 2 days a week for 3 weeks with week 4 is a rest week. Each patient will undergo three cycles.

David I Sandberg, MD

The goal of this clinical research study is to establish the maximum tolerated dose (MTD) of direct administration of methotrexate into the fourth ventricle of the brain in patients with recurrent malignant brain tumors including medulloblastoma, primitive neuroectodermal tumors (PNET), atypical teratoid/rhabdoid tumors (AT/RT), and ependymoma.

Methotrexate is designed to block cancer cells from dividing, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.

If the participant is eligible to take part in this study, the participant will have surgery to place a catheter into the ommaya reservoir. The ommaya reservoir is a catheter system that allows drugs to be administered directly to parts of the brain. This catheter will be used for the infusion of methotrexate directly into the 4th ventricle of the brain, which is 1 of the 4 connected fluid-filled cavities in the brain.

If the study doctor thinks it is necessary, based on the location of the tumor, the tumor may also be removed while the participant is already under anesthesia just before the catheter is placed.

Study Drug Administration:

The participant will receive 3 cycles of intraventricular methotrexate into the fourth ventricle. Each cycle will be of 4 weeks duration. During the first 3 weeks (Day 1-7 weekly) methotrexate will be infused twice weekly on days 1 and 4 (+/-2 days). The 4th week will be a rest week.

Methotrexate will be infused through the ommaya reservoir catheter directly into the 4th ventricle of the brain starting at a minimum of 7 days after the catheter placement surgery. A MRI will be done to confirm adequate cerebrospinal fluid flow. The infusion should last about 3 minutes each time.

If the participant already has an ommaya catheter, methotrexate will begin after an MRI has confirmed adequate cerebrospinal fluid flow.

Study Visits:

Prior to Cycle 1:

* Medical history will be reviewed and any updates to health will be recorded
* A physical with vital signs and neurological exam will be done.
* Blood (about 1 teaspoon) will be drawn for routine test
* A MRI scan of the brain and spine will be done to check the status of the disease.

On the days of Methotrexate Infusion:

* A physical with vital signs and neurological exam will be done
* A Ommaya reservoir tap (a catheter is placed into the Ommaya reservoir to give the methotrexate infusion).
* Cerebrospinal fluid (about 1 teaspoon) will be collected for routine tests.

Within 7 days of completing Cycle 3:

* A physical with vital signs and neurological exam will be done.
* A lumbar puncture will be done.
* A MRI scan of the brain and spine will be done to check the status of the disease.

Length of Study:

The participant will receive up to 3 cycles of the methotrexate, as long as the doctor thinks it is in their best interest. The participant will no longer be able to receive the study drug if the disease gets worse, if intolerable side effects occur, or if unable to follow study directions.

This is an investigational study. Methotrexate is FDA approved and commercially available for infusion directly into brain tumors. The infusion of methotrexate into the 4th ventricle of the brain is investigational,

Up to 18 patients will be enrolled in this study. All will be enrolled at Children's Memorial Hermann Hospital.

Methotrexate Infusion Into Fourth Ventricle in Children With Recurrent Malignant Fourth Ventricular Brain Tumors

Phase I Study of Methotrexate Infusion Into the Fourth Ventricle in Children With Recurrent Malignant Fourth Ventricular Brain Tumors

Maximum Tolerated Dose (MTD) is determined using the criteria established by the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events V4.0 (CTCAE).

The University of Texas Health Science Center, Houston

Director of Pediatric Neurosurgery, Associate Professor, Departments of Pediatric Surgery and Neurosurgery UTHealth Medical School

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Neoplasm Metastasis

Neoplastic Processes

Pemetrexed

Pemetrexed 20mg every 24 hours for 72 hours every 2 weeks until efficacy evaluated remission or stable ; change to every 3 weeks.

Pemetrexed 30mg D1 every week until efficacy evaluated remission or stable ; change to every 3 weeks.

Group 1（20mg）:induction stage is 20 mg per 24 hours for 72 hours, every 2 weeks; consolidation stage is 20mg per 24 hours for 72 hours, every 3 weeks.

Pemetrexed injection

Group 2（30mg）:induction stage is 30 mg D1，every week.Consolidation stage is 30 mg D1,every 3 weeks.

bin Li, doctor

xiangping Li, pharmacist

bin li, doctor

xiangping li, pharmacist

This is a open-label, multi-center prospective observation study for the efficacy and safety of intraventricle pemetrexed disodium via ommaya reservoir in the treatment of leptomeningeal metastasis with lung cancer who have failed at least one targeted therapy. In detail: At least the treatment failure was after third-generation EGFR-TKIs in EGFR-mutated lung cancer; or at least the treatment failure was after second-generation ALK-TKIs in ALK-mutated lung cancer; or at least the treatment failure was after one-line of targeted-TKIs in ROS1-mutated non-squamous non-small lung cancer.

Participants were randomizedly assigned in cohort 1 who will be given pemetrexed 20mg every 24 hours for 72 hours every 2 weeks,or in cohort 2 will be given pemetrexed 30mg once a week.

It was designed for two stages on treatment course. Induction therapy: Efficacy evaluation every 2 cycles, and confirm the efficacy at the next cycle. If at the next cycle, the efficacy result changed (such as SD or PR after initial PD; or PD after initial SD or PR; the second time of efficacy assess was required）. If the CSF cytology at the time of the efficacy evaluation was negative, one more cycle was required to confirm the CSF cytology.

Consolidation: If the efficacy is remission(including complete remission, obvious remission, or partial remission) or stable disease for initial timepoint and the timepoint of the confirmed evaluation; then the patient will be advanced to the stage of consolidation treatment. Participants in cohort 1 who will be given pemetrexed 20mg every 24 hours for 72 hours every 3 weeks. Participants in cohort 2 will be given pemetrexed 30mg every 3 weeks. Until the toxicity is intolerable, or disease progression.

Cross over： Compared the first 4 enrolled cases in each group; the comprehensive evaluation(including efficacy, cytology negative, toxicity) in better group(50% higher efficacy or 50% less toxicity) will be the following cohort, to which the other one will crossover.

Cerebrospinal fluid(CSF) supernatants are retained for the detection of cytokines and Pemetrexed concentration.

Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir

A Open-label, Random, Multi-central Prospective Cohort of Observation Study on the Efficacy and Safety of Intraventricule Pemetrexed Disodium Via Ommaya Reservoir

we will share the some dates to the website:http://www.medresman.org.cn/login.aspx or publication of results of clinical trials in the form of papers

ORR is the ratio of the patients who achieve the complete remission(CR), obvious remission(OR), or partial remission(PR) to the included patients eligible for efficacy assessment. complete remission(one of the following items): normal RANO；normal Glasgow Coma Scale；KPS≥90.

obvious remission(one of the following items): the improvement of at least 70% items on the RNAO examinations; Glasgow Coma Scale≥12 or at lease 3 scores increase compared to baseline; KPS≥70 or at lease 30 scores increase compared to baseline.

partial remission(one of the following items)：the improvement of at least 50% items on the RNAO examinations; Glasgow Coma Scale≥9 or at lease 2 scores increase compared to baseline; KPS 50-70 or at lease 20 scores increase compared to baseline.

DCR is the ratio of the patients who achieve the CR, OR, PR,or SD to the included patients eligible for efficacy assessment. complete remission(one of the following items): normal RANO；normal Glasgow Coma Scale；KPS≥90.

obvious remission(one of the following items): the improvement of at least 70% items on the RNAO examinations; Glasgow Coma Scale≥12 or at lease 3 scores increase compared to baseline; KPS≥70 or at lease 30 scores increase compared to baseline.

partial remission(one of the following items)：the improvement of at least 50% items on the RNAO examinations; Glasgow Coma Scale≥9 or at lease 2 scores increase compared to baseline; KPS 50-70 or at lease 20 scores increase compared to baseline.

stable disease (one of the following items ):the improved items on the RNAO examinations less than 50%; the change of Glasgow Coma Scale within 1 score compared to baseline; the change of KPS within 10 scores.

time to the progression of disease. Progression of disease(one of the following items): The deterioration of at least 25% items on the RNAO examinations; the drop of Glasgow Coma Scale more than 1 score compared to baseline; the drop of KPS score more than 10 scores.

negative results using glass slide centrifugation accompanied with staining

number of participants with treatment-related adverse events or severe adverse effect as assessed by CTCAE 5.0

First People's Hospital of Chenzhou

Xiangtan Central Hospital

Xiangya Hospital of Central South University

Associated professor

Rare Diseases

Medulloblastoma

Ependymoma

Rhabdoid Tumor

Etoposide

Etoposide phosphate

12 infusions of intraventricular Methotrexate and 15 infusions of intraventricular Etoposide into implanted fourth ventricle catheter/Ommaya reservoir following surgical catheter placement into fourth ventricle. Methotrexate will be infused twice weekly for 6 weeks and etoposide will be infused 5 times a week on weeks 1, 3 , and 5.

Methotrexate 4 mg into fourth ventricle of the brain via the Ommaya Reservoir 2 days a week for 6 weeks. Each patient will have 12 infusions.

Etoposide 1 mg into fourth ventricle of the brain via the Ommaya Reservoir 5 days a week for weeks 1, 3, and 5. Each patient will have 15 infusions.

Bangning L Yu, RN, PhD

David Sandberg, MD

David Sandberg, M.D.

Bangning Yu, R.N., PhD

The goal of this clinical research study is to establish the safety of simultaneous infusions of methotrexate and etoposide into the fourth ventricle of the brain or resection cavity in patients with recurrent malignant posterior fossa brain tumors. These tumors include medulloblastoma, ependymoma, atypical teratoid/rhabdoid tumor or other malignant brain tumor with recurrence or progression involving anywhere in the brain and/or spine. Patients' disease must have originated in the posterior fossa of the brain.

If the participant is eligible to take part in this study, the participant will have surgery to place a catheter into the Ommaya reservoir. The Ommaya reservoir is a catheter system that allows drugs to be administered directly to parts of the brain. This catheter will be used for the infusion of methotrexate and etoposide directly into the 4th ventricle of the brain, which is 1 of the 4 connected fluid-filled cavities in the brain.

If the study doctor thinks it is necessary, based on the location of the tumor, the tumor may also be removed while the participant is already under anesthesia just before the catheter is placed.

Study Drug Administration:

The participant will receive twice weekly 4 mg intraventricular methotrexate infusions for six consecutive weeks and daily 1 mg intraventricular etoposide infusion five times per week, every 2 weeks. Etoposide will be administered on weeks 1, 3, and 5.

Methotrexate and Etoposide will be infused though the ommaya reservoir catheter directly into the 4th ventricle of the brain starting at a minimum of 7 days after the catheter placement surgery. A MRI will be done to confirm adequate cerebrospinal fluid flow. The etoposide infusion will last 3-4 minutes and the methotrexate infusion will last 3 minutes.

If the participant already has an Ommaya catheter, methotrexate and etoposide will begin after an MRI has confirmed adequate cerebrospinal fluid flow.

Study Visits:

Prior to first infusion:

Medical history will be reviewed and any updates to health will be recorded. Physical and Neurological exam with vital signs will be done. Blood (about 1 teaspoon) will be drawn for routine test. A lumbar puncture will be done. A MRI scan of the brain and spine will be done to check the status of the disease.

On the days of the Methotrexate and Etoposide Infusion:

A neurological exam with vital signs will be done. A Ommaya reservoir tap (a catheter is placed into the Ommaya reservoir to give the methotrexate and etoposide infusion.

Cerebrospinal fluid (about 1 teaspoon) will be collected for routine tests.

Within 7 days of completing the Final infusion:

A neurological exam with vital signs will be done. A lumbar puncture and lab work will be done. A MRI scan of the brain and spine will be done to check status of the disease.

Length of Study:

The participant will receive 12 infusions of Methotrexate 4 mg and 15 infusions of Etoposide 1 mg, as long as the doctor thinks it is in their best interest. The participant will no longer be able to receive the study drug if the disease gets worse, if intolerable side effects occur, or if unable to follow study directions.

This is an investigation study. Methotrexate is FDA approved and commercially available for infusion directly into brain tumors. The infusion of methotrexate into the 4th ventricle of the brain in investigational. Etoposide is FDA approved and commercially available to be given by mouth or into the bloodstream (intravenously) but has never been given in the 4th ventricle of the brain. The infusion of methotrexate and etoposide into the 4th ventricle of the brain is investigational.

Up to 10 patients will be enrolled in this study. All will be enrolled at Children's Memorial Hermann Hospital.

Methotrexate and Etoposide Infusions Into the Fourth Ventricle in Children With Recurrent Posterior Fossa Brain Tumors

Combination Intraventricular Chemotherapy Pilot Study: Methotrexate and Etoposide Infusions Into the Fourth Ventricle or Resection Cavity in Children With Recurrent Posterior Fossa Brain Tumors

New neurological deficit defined as new cranial neuropathy, nystagmus, change in mental status, motor deficit or cerebellar finding (ataxia, dysmetria, dysdiadochokinesis) that is attributed by treating physicians to intraventricular methotrexate and etoposide infusions. Primary endpoint for basis of safety monitoring is acute toxicity occurring at any time within 30 days of receiving the intraventricular methotrexate and etoposide infusion. Rate of acute toxicity monitored using Bayesian method of Thall and Sung. Method of Kaplan and Meier used to estimate unadjusted distributions of time to a neurological deficit and progression free survival time and summary statistic of all variable computed and tabulated

Director of Pediatric Neurosurgery, Associate Professor Pediatric Surgery and Neurosurgery

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hematologic Neoplasms

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

B-cell Lymphoma

Acute Graft Versus Host Disease

Dose escalation follows the standard 3+3 doseescalation design. A total of 3 dose levels are set for subjects.

Each subject receive CAR T-cells by intravenous infusion

CAR-T cells

He Huang, PhD

Yongxian Hu, PhD

A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory central nervous system CD19+ B-cell hematological malignancies, including acute lymphoblastic leukemia and B-cell non-Hodgkin's lymphoma. The selections of dose levels and the numberof subjects are based on clinical trialsof similar foreign products. Two groups of patients will be enrolled, 36 in eachgroup. Primary objective is to explore the safety, main consideration is dose-related safety.

Clinical Trial for the Safety and Efficacy of CAR-T Cells Therapy for Patients With the Central Nervous System Involvement of Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia or B-cell Non-Hodgkin's Lymphoma

Adverse events assessed according to NCI-CTCAE v5.0 criteria

Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Assessment of ORR (ORR = CR + CRi) at Month 6, 12, 18 and 24

From the first infusion of CAR-T cells to death or the last visit

From the first infusion of CAR-T cells to the occurrence of any event, including death, relapse orgene relapse, disease progression (any one occurs first), and the last visit

Assessment of ORR (ORR = CR + PR) per Lugano 2014 criteria

Assessment of DCR (DCR=CR+PR+SD) per Lugano 2014 criteria

Assessment of Quality of life using Research and Treatment of Cancer QOL Core Questionnaire 30 (EORTC QLQ-30) at Baseline, Month 1, 3, 6, 9 and 12

Assessment of IADL score at Baseline, Month 1, 3, 6, 9 and 12

Assessment of ADL score at Baseline, Month 1, 3, 6, 9 and 12

Assessment of Hospital Anxiety and Depression Scale (HADS) score at Baseline, Month 1, 3, 6, 9 and 12

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Methotrexate Infusion Into Fourth Ventricle in Children With Recurrent Malignant Fourth Ventricular Brain Tumors	NCT02458339	Brain Tumor, Re... Malignant Neopl...	Ommaya Reservoi... Methotrexate	1 Year - 21 Years	The University of Texas Health Science Center, Houston
Methotrexate Infusion Into Fourth Ventricle in Children With Recurrent Malignant Fourth Ventricular Brain Tumors	NCT02458339	Brain Tumor, Re... Malignant Neopl...	Ommaya Reservoi... Methotrexate	1 Year - 21 Years	The University of Texas Health Science Center, Houston
Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir	NCT06399926	Leptomeningeal ... Lung Cancer	Pemetrexed inje... Pemetrexed	18 Years -	Xiangya Hospital of Central South University
Methotrexate Infusion Into Fourth Ventricle in Children With Recurrent Malignant Fourth Ventricular Brain Tumors	NCT02458339	Brain Tumor, Re... Malignant Neopl...	Ommaya Reservoi... Methotrexate	1 Year - 21 Years	The University of Texas Health Science Center, Houston
Methotrexate and Etoposide Infusions Into the Fourth Ventricle in Children With Recurrent Posterior Fossa Brain Tumors	NCT02905110	Brain Tumor Rec...	Methotrexate Etoposide Ommaya Reservoi...	1 Year - 80 Years	The University of Texas Health Science Center, Houston
Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir	NCT06399926	Leptomeningeal ... Lung Cancer	Pemetrexed inje... Pemetrexed	18 Years -	Xiangya Hospital of Central South University
A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies	NCT04532203	Acute Lymphobla... Non-Hodgkin's L...	CAR-T cells Ommaya Reservoi...	3 Years - 75 Years	Zhejiang University

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