Neoplasms

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Rare Diseases

Glioma

Communication Disorders

Neurobehavioral Manifestations

Neurologic Manifestations

Neurodevelopmental Disorders

Mental Disorders

Psychotic Disorders

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

In the experimental arm, patients will receive 6 sessions of sophrology. The sessions are individual and last approximately 50 minutes.

In addition to the sophrology sessions, patients will benefit from two speech therapy sessions per week for 6 months, lasting from 30 minutes to 1 hour depending on the patient's general condition.

Patients will benefit from two speech therapy sessions per week for 6 months, lasting from 30 minutes to 1 hour depending on the patient's general condition.

Sophrology is a relaxation method that's sometimes referred to as hypnosis, psychotherapy, or a complementary therapy.

Sophrology uses techniques such as: hypnosis, visualization, meditation, mindfulness, breathing exercises, gentle movements, body awareness...

Sophrology techniques may be useful during medical procedures that cause stress and discomfort.

Sophrology techniques may be useful during medical procedures that cause stress and discomfort.

Patients will receive 6 sessions of sophrology

Sophrology

Speech therapy is a treatment that can help improve communication skills. patients will benefit from two speech therapy sessions per week for 6 months, lasting from 30 minutes to 1 hour depending on the patient's general condition.

Speech therapy

CELINE THOMAS

MARINE TIGREAT

Patients with brain tumours experience a loss of independence, which may occur suddenly or gradually. Communication with the patient may be rapidly impaired, due to impaired alertness, language and/or neurocognitive disorders.

In addition to these clinical symptoms, there is a high level of anxiety and depression in this population due to the severity of the diagnosis, with a major impact on the patients' quality of life. In this study, we are mainly interested in the proportion of this population with communication disorders where speech therapy is important In order to better take into account anxiety, which is often difficult to verbalise due to communication problems, sophrology can be proposed as an alternative to psychological support, which is often too complicated or inappropriate.

After having noted positive feedback from patients after joint speech therapy and sophrology treatment, we wish to evaluate the interest of coupling sophrology treatment for patients with glial tumours requiring speech therapy.

Our hypothesis is that this association would improve the level of anxiety, the quality of life and have a positive impact on the patient's speech therapy.

Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy

Anxiety levels will be measured using the Hospital Anxiety and Depression Scale at 6 months in both treatment arms. The quality of life scale consists of 14 items scored from 0 to 3. A score of 0 indicates that the patient has no anxiety disorder, a score of 21 indicates that the patient has a severe anxiety disorder.

Quality of life will be assessed by quality of life questionnaires at baseline and after 3 and 6 months of treatment. These are the QLQ-C30 v3 questionnaire and the brain-specific module EORTC-BN20 ;

Institut Cancerologie de l'Ouest

Recurrence

Glioblastoma

Central Nervous System Neoplasms

Medulloblastoma

Meningioma

Nervous System Neoplasms

Pinealoma

Astrocytoma

Ependymoma

Oligodendroglioma

Rhabdoid Tumor

Gliosarcoma

Choroid Plexus Neoplasms

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Brain Neoplasms

Brain Diseases

Central Nervous System Diseases

Cerebral Ventricle Neoplasms

Pineocytoma

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Diffuse Astrocytoma

Pilocytic Astrocytoma

Pleomorphic Xanthoastrocytoma

Gliomatosis Cerebri

Anaplastic Pleomorphic Xanthoastrocytoma

ONC206 is a member of the imipridone class of anti-cancer small molecules that share a unique tri-heterocyclic core chemical structure and target G protein-coupled receptors.

ONC206

Chris Tedesco

Marion Morrison, MD

Referrals

Kelly Mentges, RN

Mark Gilbert, MD

The primary objective of this Phase 1, open-label, dose-escalation, and exploratory study is to evaluate the safety and tolerability profile (establish the maximum-tolerated dose) and evaluate the occurrence of dose-limiting toxicities (DLTs) following single weekly or multiple-day weekly dose regimens of single-agent, oral ONC206 in patients with recurrent, primary central nervous system (CNS) neoplasms.

This is a Phase I, open-label, dose-escalation, and exploratory study of ONC206 in patients with recurrent, primary CNS neoplasms. All patients will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures.

There will be a total of 11 Dose Levels. Dose-escalation for Dose Levels 1 through 5 proceeded according to standard 3+3 design using a 28-day DLT window. The first cohort of 3 patients enrolled into the study received Dose Level 1 followed by increments as per the modified Fibonacci sequence. It is anticipated that approximately 46 patients will be enrolled in order to determine the MTD of ONC206.

For Dose Levels 1 through 5, a safety evaluation was conducted when 3 evaluable patients have completed 1 cycle (28 days) of therapy. After Protocol Amendment 6, all available PK data will also be considered for dose escalation decisions. Dose levels may be adjusted based on review of PK data but will not exceed maximum dose levels described in Table 6. Additionally, dose frequencies (e.g., once daily or 3 times daily) may be added and/or removed based on emerging PK data and concentration projections.

Prior to advancing/changing dose levels, a cohort summary must be completed and submitted to the sponsor Medical Monitor, for review and approval. Dose escalation for subsequent patients will proceed as follows:

* If no DLT is reported at a dose level, that dose level will be considered safe, and patient(s) will be enrolled at the next dose level. Toxicity information will continue to be evaluated from the time of the first protocol specific intervention, until 30 days from the last dose of study drug.
* If 1 patient in a cohort of 1 experiences a DLT, the dose level will be expanded to obtain an additional 2 evaluable patients.
* If 1 patient in a cohort at a dose level experiences a DLT, the dose level will be expanded to obtain an additional 3 evaluable patients.
* If 2 of 3 patients in a cohort at a dose level experience a DLT, that dose level will not be considered safe, no further dose escalation will take place, and the MTD will have been exceeded\*.
* If 1 patient experiences a DLT among the expanded cohort of evaluable patients, a cohort of 3 patients will be enrolled in the next higher dose level.
* If 2 or more patients experience a DLT among the expanded cohort of evaluable patients, that dose level will not be considered safe, no further dose escalation will take place, and the MTD will have been exceeded\*. The previous dose level at which ≤1 patients experienced a DLT will be declared the MTD.

  * When the MTD has been exceeded:

If less than 6 patients have been treated in the next lower dose level (the possible MTD level), additional patients will be entered into this dose level until there are 6 patients treated. If ≤1 of these 6 patients encountered DLT, then this dose level will be declared to be the MTD. If 2 or more of the 6 patients encounter DLT, then the MTD has been exceeded.

Given the experience with ONC201, it is possible a MTD may not be reached through the planned dose escalation cohorts. If the therapeutic target concentrations have been achieved in the dose escalation cohorts, and no DLT has been identified, then analysis of the safety and PK data will be evaluated by the Investigators and the Sponsor. Further dose levels may then be considered at higher intermittent dosing schedules and will be added by protocol amendment with review by the Institutional Review Board (IRB) before implementation.

Toxicities will be graded using the Common Terminology Criteria for Adverse Events Version 24.0 (CTCAE 24.0). If the CTCAE 24.0 does not apply to an adverse event, it will be graded as mild, moderate, or severe.

DLTs will be assessed during the first course of each cohort (28 days), and refers to a study drug related or possibly related event that meets 1 of the following criteria using the NCI CTCAE version 5.0:

* Grade 3 or higher non-hematologic toxicity.
* Grade 4 hematologic toxicity (ANC \<0.5 × 109/L and platelet count \<25 × 109/L). Lymphopenia is not considered a DLT. A confirmed DLT requires 2 consecutive measurements separated by 48 hours.
* Grade 3 neutropenia (ANC \<1.0 × 109/L) with elevated fever (\>101°F). A confirmed DLT requires 2 consecutive measurements.
* Grade 3 thrombocytopenia with clinically significant bleeding.
* Inability to receive the scheduled Cycle 2, Day 1 dose of study drug within 14 days due to study drug-related toxicity persisting from Cycle 1 or study drug-related toxicity newly encountered on Day 1 of Cycle 2.

Safety and tolerability will be monitored by assessing physical examinations including height (at Screening only) and weight, KPS, vital signs, ECG, laboratory assessments including hematology, chemistry, and coagulation, as well as collecting of the AEs at every visit.

Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

A First-in-human Phase I Single-agent Dose-escalation, Food Effect and Dose Expansion Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

MTD was determined by testing increasing doses up to 200 mg twice daily for 3 successive days a week.

MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in \>33% of participants. DLTs will be assessed in the first course of each cohort (28 days), and refer to a study drug-related or possibly related event that meets 1 of the following criteria defined in the subsequent Primary Outcome Measure using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE 5.0).

DLTs will be assessed in the first course of each cohort (28 days), and refer to a study drug-related or possibly related event that meets 1 of the following criteria using NCI CTCAE 5.0:

* Grade 3 or higher non-hematologic toxicity.
* Grade 4 hematologic toxicity (ANC \<0.5 × 109/L and platelet count \<25 × 109/L). Lymphopenia is not considered a DLT. A confirmed DLT requires 2 consecutive measurements separated by 48 hours.
* Grade 3 neutropenia (absolute neutrophil count \[ANC\] \<1.0 × 109/L) with elevated fever (\>101°F). A confirmed DLT requires 2 consecutive measurements.
* Grade 3 thrombocytopenia with clinically significant bleeding.
* Inability to receive the scheduled Cycle 2, Day 1 dose of study drug within 14 days due to study drug-related toxicity persisting from Cycle 1 or study drug-related toxicity newly encountered on Day 1 of Cycle 2.

National Institutes of Health (NIH)

Chimerix

Gland and Hormone Related Diseases

Neoplasm Metastasis

Pituitary Diseases

Neurilemmoma

Pituitary Neoplasms

Hypothalamic Diseases

Endocrine System Diseases

Neuroendocrine Tumors

Neuroma

Nerve Sheath Neoplasms

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Schwannoma

Neuroendocrine Tumor

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

During tumor resection, study investigators trained in the use of the system will determine when the CONVIVO imaging system will be used for in vivo¬ imaging. At this point 5 mg/kg of fluorescein will be administered intravenously by an anesthesia provider over one minute.Approximately 2-5 minutes following administration of FNa in situ imaging will be performed by the participating surgeon ensuring proper technique.

Following image acquisition, the tissue region imaged with the CONVIVO system will then be biopsied using biopsy forceps. This will be passed immediately off the surgical field as a research specimen and provided to a member of the research team to be prepared for conventional histologic evaluation. The specimen will be labeled with the deidentified subject and sample number. This sequence will then be repeated for each successive sample.

Approximately 2-5 minutes following administration of FNa in situ imaging will be performed by the participating surgeon ensuring proper technique. Prior to entering the surgical field, the probe will be covered in a disposable sterile sheath that is manufactured with quality assurance for this purpose. The probe will gently be held against the tissue interface while imaging occurs. Again this will only be in regions that would normally be resected or sampled in routine clinical care. Following image acquisition, a neuropathologist present in the operating room, will review and capture each image.

CONVIVO system

Conventional histologic evaluation

Linton T Evans, MD

The primary objective of this study is to evaluate the diagnostic performance of the CONVIVO confocal endomicroscope in discriminating between normal and abnormal tissue in vivo during brain tumor surgery. The interpretation of intraoperative images obtained in situ will be tested against conventional histologic evaluation of targeted biopsies from imaged tissue. The study team hypothesize that there will be a high degree of correlation between images obtained with the CONVIVO system and conventional histologic interpretation.

The surgical resection of brain tumors is an integral component of modern neuro-oncology. . Extent of resection has been found to be associated with increased overall and progression free survival, with the greatest benefit occurring in the setting of a complete or gross total resection. Unfortunately, there are a number of obstacles unique to brain tumors that may limit the extent of resection. A number of advancements in neurosurgical oncology have emerged to improve the extent of tumor resection while decreasing operative morbidity and mortality. Confocal reflectance microscopy is a routine technique used to visualize tissues without fixation or staining used in classical histological techniques. Laser scanning confocal microscopy (LSCM) is an optical fluorescence imaging modality used for imaging thick in vivo and ex vivo tissues. Clinically available confocal endomicroscopy systems contain lasers with precise excitation wavelengths and dichroic filters for detecting appropriate emission wave lengths. The studies completed to date do not evaluate the ability of confocal microscopy to discriminate between normal and abnormal tissue at the margins during surgical resection. This is the first of such in vivo feasibility studies that aims to demonstrate this claim of the CONVIVO system.

The images acquired with the CONVIVO system following administration of fluorescein will be compared to conventional histologic specimens from corresponding biopsies. This is a planned single center study. This study is designed to assess the diagnostic accuracy of the CONVIVO system compared with gold-standard histopathology in tissue that has already been identified for resection. The device will not be used to inform surgical decision making, nor will tissue that would not otherwise be resected be biopsied for research purposes.

This study will rely on study investigators, all physicians at Dartmouth-Hitchcock, to identify subjects. Written consent is required for participation in the study.. There are no specific medical risks to patients associated with the use of CONVIVO. It is not anticipated that there are immediate or direct benefits to patients participating in this study. The CONVIVO imaging data acquired during the procedure will be initially stored on the device's hard drive and later securely uploaded to an encrypted Dartmouth-Hitchcock server. Patients will have the ability to maintain their privacy with minimal disruption or contact by the study team. Additionally, the PI or other investigators will have interactions with the patient as part of their routine clinical care. Participants are free to withdraw from participation in the study at any time upon request.

Adult patients (age\>18) presenting with suspected intracranial gliomas (including glioblastoma), cerebral metastasis, meningiomas, acoustic neuromas, and pituitary adenomas, who are surgical candidates and provide informed consent.

Evaluation of the CONVIVO System

Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal From Abnormal Tissue During Brain Tumor Resection

There are no plans at this time to share IPD.

Concordance between in vivo imaging with the CONVIVO system and conventional histologic assessment.The diagnostic performance of the CONVIVO system will be assessed with respect to classification as "normal" or "abnormal" tissue. The interpretation of intraoperative images obtained in situ will be tested against conventional histologic evaluation of targeted biopsies from imaged tissue. Pertinent tumors include all intracranial neoplasms including low and high grade glial neoplasms, glioneuronal tumors, cerebral metastasis, meningioma, schwannoma, and pituitary lesions.

Degree of concordance between in vivo imaging with the CONVIVO system and conventional histologic assessment or frozen with respect to histologic diagnosis.

Sensitivity and specificity analysis of CONVIVO using area under the curve and receiver operating characteristics. Conventional histopathology will be the gold-standard.

Rate of uninterpretable or non-diagnostic imaging with the CONVIVO system. During the resection the PI or other investigators may image tissue that is ultimately not biopsied. For example at the end of resection if there is a region of interest that cannot be safely resected, the CONVIVO system can be used to image the tissue without obtaining a corresponding tissue specimen for histology. During image acquisition it will be noted and documented by the research team that there is not a corresponding tissue specimen.

MRI characteristics will include (i) the presence or absence of contrast enhancement; (ii) signal intensity on T2 weighted images; (iii) perfusion based and spectroscopy imaging; (iv) diffusion weighted sequences.

Following image coregistration, the 560 yellow light filter on the Kinevo microscope will be used to determine the visible fluorescence in the region that was interrogated and classified from 0 to 4 based upon the fluorescence intensity. This will be recorded by the research team. The degree of visible fluorescence will be graded as 0-no fluorescence, 1- weak intensity, 2-moderate intensity, 3-strong intensity.

If the participant has also received 5-ALA, the 400 nm blue light filter will then be selected and the visible fluorescence of PPIX will also be classified from 0 to 4 based upon the fluorescence intensity. The degree of visible fluorescence will be graded as 0-no fluorescence, 1- weak intensity, 2- moderate intensity, 3-strong intensity.

Extent of resection has been found to be associated with increased overall and progression free survival, with the greatest benefit occurring in the setting of a complete or gross total resection. Postoperative MRI is obtained as appropriate, as it relates to extent of resection.

Record adverse events as reported by participant or observed by investigator related to the administration of fluorescein

Time to pathologic interpretation of intraoperative imaging compared to conventional interpretation of histology.Currently, the frozen section provides intraoperative histopathological analysis of brain tumors. Though useful, this process is time consuming and requires the cutting, freezing, and staining of several biopsies.

The WHO criteria for the diagnosis of Glioblastoma (GBM) - cell density, cellular pleomorphism, increased mitoses, microvascular proliferation and trpalisading or ischemic necrosis - were all detectable by Confocal EndoMicroscope (CEM). Identification of the infiltration zone or the center of the tumor was possible based upon assessments of cell density comparing the center and border specimens. Additional aspects, e.g. apoptotic figures in perinecrotic pseudopalisading tumor cells, and important histological structures such as giant cells, fibrillary tumor matrix and blood vessels were also visible with CEM. Typical features of CEM in patients with histologically proven meningioma were also seen.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy	NCT05189366	Glial Tumor	Sophrology Speech therapy	-	Institut Cancerologie de l'Ouest
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms	NCT04541082	Central Nervous... Glioblastoma Gliosarcoma, Ad... Anaplastic Olig... Anaplastic Astr... Pilocytic Astro... Oligodendroglio... Gliomatosis Cer... Pleomorphic Xan... Anaplastic Pleo... Diffuse Midline... Ependymoma Ependymoma, Ana... Medulloblastoma Teratoid Rhabdo... Neuroectodermal... Neuroectodermal... Anaplastic Meni... Atypical Mening... Choroid Plexus ... Pineal Tumor Diffuse Astrocy... Glial Tumor	ONC206	18 Years -	Chimerix
Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy	NCT05189366	Glial Tumor	Sophrology Speech therapy	-	Institut Cancerologie de l'Ouest
Evaluation of the CONVIVO System	NCT05139277	Glioblastoma Glial Tumor Brain Metastase... Meningioma Schwannoma Pituitary Tumor	CONVIVO system Conventional hi...	18 Years -	Dartmouth-Hitchcock Medical Center

Spots Global Cancer Trial Database for glial tumor

Every month we try and update this database with for glial tumor 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 glial tumor

Every month we try and update this database with for glial tumor 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 glial tumor 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.