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16 active trials for Brain Tumors

Analysis of Data Collected From Individuals Administered Neurobehavioral Assessments

Background: People with chronic illness often are at risk for developing neurobehavioral problems due to effects of the disease or associated treatments. These problems may include cognitive impairments involving problem-solving, remembering things, paying attention, and understanding and using language, or emotional functioning or quality of life. The National Cancer Institute Medical Illness Counseling Center Neuropsychology Group has collected data from neurobehavioral evaluations of infants, children, adolescents and adults with chronic illnesses enrolled in NIH protocols since 1987 and continues to collect data from patients enrolled in current protocols. The data from these evaluations, along with demographic and medical information are stored in an NIH computer database. Investigating the neurobehavioral functioning of patients with chronic illness is important for identifying and monitoring the effects of the disease and treatments over time, determining possible at-risk subgroups, evaluating response to therapy, and recommending educational and rehabilitative interventions. Objectives: -To learn about how certain illnesses or treatments may affect a person s cognitive abilities, emotional functioning and quality of life. Eligibility: Patients currently enrolled in NIH studies who are having neuropsychological testing or completing quality-of-life questionnaires as part of that study. Data obtained from infants, children, adolescents, and adults administered neurobehavioral assessments as part of a past or future NIH protocol. Design: This study does not involve any extra tests or questionnaires; it uses information collected from evaluations that subjects have already completed or will complete as part of other NIH studies. Information about participating patients that may help elucidate how cognitive abilities, emotional functioning, and quality of life are affected in people with chronic illness may be collected and stored.

Start: March 2007

Evaluating the Expression Levels of MicroRNA-10b in Patients With Gliomas

MicroRNAs (miRNA) are molecular biomarkers that post-transcriptionally control target genes. Deregulated miRNA expression has been observed in diverse cancers. In high grade gliomas, known as glioblastomas, the investigators have identified an oncogenic miRNA, miRNA-10b (mir-10b) that is expressed at higher levels in glioblastomas than in normal brain tissue. This study tests the hypothesis that in primary glioma samples mir-10b expression patterns will serve as a prognostic and diagnostic marker. This study will also characterize the phenotypic and genotypic diversity of glioma subclasses. Furthermore, considering the critical function of anti-mir-10b in blocking established glioblastoma growth, the investigators will test in vitro the sensitivity of individual primary tumors to anti-mir-10b treatment. Tumor, blood and cerebrospinal fluid samples will be obtained from patients diagnosed with gliomas over a period of two years. These samples will be examined for mir-10b expression levels. Patient survival, as well as tumor grade and genotypic variations will be correlated to mir-10b expression levels.

Start: May 2013

ALA-induced PpIX Fluorescence During Brain Tumor Resection

Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of the patient's tumor by looking at the MRI images that were taken of the patient's brain before surgery. However, the surgeon does not have any good way to tell if the entire tumor has been removed or not. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease the chances of survival.

Start: July 2014

1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients

The purpose of this study is to see if there are any differences between patients who receive Levetiracetam extended-release tablets for one week after surgery to remove a brain tumor versus those who receive Levetiracetam extended-release tablets for six weeks after surgery. Specifically, we will see if one group has less side effects than the other, and whether or not one group has more seizures than the other.

Start: August 2015

Comparison of Proton and Photon Radiotherapy of Brain Tumors (ProtoChoice-Hirn)

This protocol compares the toxicity of radiotherapy or radiochemotherapy applied with different radiation modalities - protons or photons. Patients with different kinds of brain tumours and foreseen high-dose radiotherapy can be included. The hypothesis of the trial is that the rate of chronic toxicity 1 year after the end of radiotherapy is 15% lower after proton compared to photon treatment.

Start: July 2016

Understanding Communication in Healthcare to Achieve Trust (U-CHAT)

Honest, clear, and empathetic communication between pediatric oncologists (POs) and parents of children with cancer (POCCs) is imperative to facilitating therapeutic alliance and ensuring that medical management aligns with the families' goals of care. Communication is particularly important during conversations about disease reevaluation, which often necessitate parental decision-making in the context of emotional distress. POs employ a spectrum of communication styles and strategies during challenging conversations, and there is no consensus regarding linguistic or thematic metrics for high quality communication of upsetting information. In order to better understand how POs communicate difficult information to POCCs, the investigators propose a pilot study designed to accomplish the following primary aim: Primary Objective: To identify recurrent verbal and nonverbal (e.g. the use of pauses/silence) communication techniques employed by POs in the delivery of difficult prognostic information to POCCs through content analysis of audio-recorded conversations between POs and parents of children with high risk cancer at the time of disease reevaluation. The study expects to enroll up to: 80 patient participants, 80 parents, and 15 primary pediatric oncologists (total = 175). Non-primary oncologist members of the clinical care team, extended family members, or friends of the family may also participate, if they choose to do so.

Start: September 2016

Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing

Background. Survivors of childhood brain tumours have the poorest health-related quality of life of all cancer survivors due to the multiple physical and psychological sequelae of brain tumours and their treatment. Remotely delivered Acceptance and Commitment Therapy (ACT) may be a suitable and accessible psychological intervention to support young people who have survived brain tumours. Aims. This study aims to assess the feasibility and acceptability of remotely delivered ACT to improve quality of life among young brain tumour survivors. Method. This study is a two-arm, parallel group, randomised controlled trial comparing ACT with waitlist control. Participants will be aged 11-24 years and survivors of brain tumours who have completed cancer treatment. Participants will be randomised to receive 12 weeks of ACT either immediately or after a 12-week wait. The durability of treatment effects will be assessed by further follow-up assessments at 24-, 36- and 48- weeks. The DNA-v model of ACT will be employed, which is a developmentally appropriate model for young people. Feasibility will be assessed using the proportion of those showing interest who consent to the trial and complete the intervention. A range of clinical outcome measures will also assess physical and mental health, everyday functioning, quality of life and service usage. Acceptability will be assessed using participant evaluations of the intervention, alongside qualitative interviews and treatment diaries analysed thematically. Discussion. This study will provide an initial assessment of the value of remotely delivered ACT in supporting recovery and coping for young people after brain tumour treatment.

Start: February 2021

Molecular-Guided Therapy for Relapsed and Refractory Childhood Cancer

The purpose of this study is to test the feasibility (ability to be done) of experimental technologies to determine a tumor's molecular makeup (gene expression profile) and mutations. This technology called the "Pediatric Gene Analysis Platform" includes a genomic report (gene expression profile) and a DNA Mutation Panel Report that are being used to discover new ways to understand cancers and potentially predict the best treatments for patients with cancer in the future.

Start: February 2013

Brain Areas of Time-To-Contact Perception: an Awake Surgery Study

During a brain surgery targeted to remove a brain tumor, the neurosurgeon wakes up the patient to delimit the tumor area exactly, and identify the surrounding areas, to limit the surgery damages. The present project aims at testing the patient in this awake phase to determine the brain areas implied in time to contact (TTC) perception, a function that allows determining the arrival time of moving objects and used in many tasks of our daily life.

Start: September 2019

A Pilot RCT of the PRISM Intervention for AYAs With Cancer

Study Title: A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Adolescents and Young Adults with Cancer Study Population and Sample Size: Two cohorts of Adolescent and Young Adult (AYA) patients with diagnosis of new or recurrent cancer between 1 and 10 weeks prior to enrollment: those ages 13-17 (N=50); (2) those ages 18-25 (N=50). Study Design: Pilot randomized controlled trial (RCT). Primary Objective: To test the efficacy of the "Promoting Resilience in Stress Management" (PRISM) among Adolescents and Young Adults with cancer. Primary Outcome: Change in patient-reported resilience (based on score of standardized Connor-Davidson Resilience Scale) at 6 months. Secondary Outcomes: Patient-reported resilience at 2, 4, and 12 months Patient-reported self-efficacy, benefit-finding, psychological distress, quality of life, and health-behaviors at 6 and 12 months. Qualitative assessment of patient-reported goals at 6 and 12 months Development of a cohort of AYA cancer survivors for assessment of long-term psychosocial outcomes Study Duration: 3 years

Start: January 2015

Tryptophan Metabolism in Human Brain Tumors

The main purpose of this study is to determine the potential clinical utility of PET imaging using the radiotracer [C-11]alpha-methyl-L-tryptophan in the diagnosis, differentiation and monitoring of various brain tumors, both before and after initial treatment. We will also study mechanisms and clinical significance of abnormal brain tumor tryptophan metabolism using resected tumor tissues.

Start: February 2014

Blood Flow MRI for Monitoring Brain Tumors

The investigators are studying the use of an advanced magnetic resonance imaging (MRI) technique for measuring blood flow into brain tumors. This technique does not use radioactive tracers, and it can provide high quality images that can be obtained in a standard MRI scanner.

Start: June 2006

Quality Improvement and Practice Based Research in Neurology Using the EMR

The investigators will conduct at NorthShore University HealthSystem pragmatic trials using the EMR for 10 common neurological disorders. They will demonstrate the feasibility of subgroup based adaptive assignment of treatments, electronic consenting, and outcomes data capture at the point of care using the EMR. They will identify the most effective treatments for common neurological disorders and seek replication by the NPBRN.

Start: May 2016

Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-central Nervous System (Non-CNS) Malignancies

In recent years, remarkable advances in medical oncology, surgery, and radiology have allowed for increasing cure rates for childhood malignancies. This success has led to an emerging understanding of the kinds of effects that treatments can have on the pediatric population and how such effects can influence pediatric cancer survivor's functioning and quality of life. It has become tremendously important to assess the long-term complications due to therapy in this growing sector of survivors and to tailor our treatments so as to minimize these late effects. The Investigators at MGH are committed to improving the delivery of radiotherapy to our patients and improving the outcome for these patients. MGH has an on-site cyclotron for proton radiotherapy in order to provide the most advanced care for patients in need. Proton therapy possesses a clinical advantage over standard photon therapy in that its optimal dose distribution delivers the bulk of radiation to the tumor site. This method spares the greatest volume of normal tissue, resulting in decreased short-term and long-term morbidity. Through open pediatric protocols for patients treated with proton radiotherapy, the investigators aim to define and report the acute and late effects associated with treatment. The investigators also treat a number of patients off-protocol with both proton and photon radiotherapy, and are interested in reporting these patients' QOL outcomes in conjunction with other clinical data that may be pertinent to the site of tumor treatment. This research is significant in that it will allow us to delineate the positive and negative effects of radiation treatment on patients' QOL, highlighting points of success and exposing areas that are in need of improvement. Such knowledge will be used to improve the experience of pediatric cancer survivors in the future. The aims of this study are: 1) to prospectively collect and report the QOL outcomes in patients treated with radiotherapy and 2) to correlate the QOL data with pertinent clinical information.

Start: September 2005

Advanced MRI Applications Development

The goals of this study are to: To improve upon and develop new innovative magnetic resonance imaging techniques that refine image quality and enhance performance. Improvements in these areas will have positive implications for medical diagnosis and treatment. To correlate MRI images with underlying disease pathophysiology in order to ensure that imaging accurately reflects the disease process.

Start: January 2014

International Society of Paediatric Oncology (SIOP) PNET 5 Medulloblastoma

The study PNET 5 MB has been designed for children with medulloblastoma of standard risk (according to the risk-group definitions which have been used so far; e.g. in PNET 4). With the advent of biological parameters for stratification into clinical medulloblastoma trials, the ß-catenin status will be the only criterion according to which study patients will be assigned to either treatment arm PNET 5 MB - LR or to PNET 5 MB - SR, respectively. The initial diagnostic assessments (imaging, staging, histology, and tumor biology) required for study entry are the same for both treatment arms.

Start: June 2014