Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With...
1p/19q Co-deletionAnaplastic Astrocytoma7 moreThis randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma. Proton beam radiation therapy uses tiny charged particles to deliver radiation directly to the tumor and may cause less damage to normal tissue. Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. Patients will be more likely to be randomized to proton beam radiation therapy. It is not yet known if proton beam radiation therapy is more effective than photon-based beam intensity-modulated radiation therapy in treating patients with glioma.
SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue
Brain TumourHigh Grade Glioma2 moreThe objective of this clinical investigation is to assess the safety and performance of the SonoClear Acoustic Coupling Fluid (ACF). The performance will be assessed by analysis of the contrast-to-noise ratio (CNR) and assessment of image quality by using the Surgeon Image Rating (SIR) Scale. This is a prospective, multi-centre single-arm study where the performance of SonoClear ACF relative to routinely used acoustic coupling fluid is investigated by each patient being their own control. Patients with the diagnosis of HGG and LGG at up to 10 sites will be included. Additionally, safety data are collected at 30 days and 6 months post-procedure.
Telehealth Visits to Discuss Advanced Directives for Patients Newly Diagnosed With High Grade Glioma...
GliomaHigh grade gliomas (HGGs) are rapidly progressive brain tumors resulting in death for most patients between 6 months and 2 years after diagnosis. It is important for patients with HGG to discuss and document their wishes at the end of life. However, many of these patients experience early changes in cognition which impede their decision-making. For this reason, these patients should have early discussions with their providers. However, implementation of this remains challenging in clinical practice. In this study, we will create an Early STructured Advanced care Referrals by Telehealth (Early START) visit for patients soon after their initial oncology visit. A checklist and pre-visit guide were developed to help guide the visit for both the provider and patient. Providers will receive special training in running these visits. Caregivers and/or family members will be encouraged to participate. Visits will be done using video or telephone and recorded. For patients who do not have access to technology for these visits, it will be provided. After the visit, patients, caregivers and/or family who participated, and providers will fill out surveys to address feasibility of having these extra visits and improve the visits for future. Patients will be followed until death. Caregivers and/or family who participated will be asked about whether end of life was in line with the patient's wishes. We will also use the patient's medical record to assess other aspects of end of life. We will compare end of life outcomes with other similar patients treated at our center.
Simulation-Based Caregiving Skills Training for Family Members of High Grade Glioma Patients
GliomaFamily caregivers of patients with a primary brain tumor experience a high caregiving load including assistance with activities of daily living without any formal training. It is not surprising that this vulnerable caregiver population reports high levels of distress along with numerous caregiving-related concerns, which may compromise their ability to provide quality care. This project will examine the feasibility and initial evidence for efficacy of a caregiving skills intervention aiming to improve caregiver and patient psychological health; caregiving efficacy and role adjustment; and reduce patient cancer-related symptoms and healthcare utilization.
Low-dose Bevacizumab With HSRT vs BVZ Alone for GBM at First Recurrence
GliomaRecurrent GliomaThis randomized phase II trial studies how well lose dose bevacizumab with Hypofractionated Stereotactic Radiotherapy (HSRT) works versus bevacizumab alone in treating patients with glioblastoma at first recurrence. The primary endpoint is 6-month progress-free survivaloverall survival after the treatment. Secondary endpoints included overall survival, objective response rate, cognitive function, quality of life and toxicity.
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade...
WHO Grade II GliomaThis Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
HSV G207 Alone or With a Single Radiation Dose in Children With Progressive or Recurrent Supratentorial...
Supratentorial NeoplasmsMalignant6 moreThis study is a clinical trial to determine the safety of injecting G207 (a new experimental virus therapy) into a recurrent or progressive brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication and tumor cell killing, will also be tested.
Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma
OligodendrogliomaAstrocytoma7 moreThis is a pilot neoadjuvant vaccine study in adults with WHO grade II glioma, for which surgical resection of the tumor is clinically indicated. Co-primary objectives are to determine: 1) the safety and feasibility of the neoadjuvant approach; and 2) whether the regimen increases the level of type-1 chemokine CXCL10 and vaccine-specific (i.e., reactive to GBM6-AD) CD8+ T-cells in tumor-infiltrating leukocytes (TILs) in the surgically resected glioma.
A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade...
GliomaMalignant Glioma7 moreThis is a pilot, randomized, two arm neoadjuvant vaccine study in human leukocyte antigen-A2 positive (HLA-A2+) adults with World Health Organization (WHO) grade II glioma, for which surgical resection of the tumor is clinically indicated. Co-primary objectives are to determine: 1) the safety of the novel combination of subcutaneously administered IMA950 peptides and poly-ICLC (Hiltonol) and i.v. administered CDX-1127 (Varlilumab) in the neoadjuvant approach; and 2) whether addition of i.v. CDX-1127 (Varlilumab) increases the response rate and magnitude of CD4+ and CD8+ T-cell responses against the IMA950 peptides in post-vaccine peripheral blood mononuclear cell (PBMC) samples obtained from participating patients.
Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin...
Advanced Malignant Solid NeoplasmAnn Arbor Stage III Childhood Non-Hodgkin Lymphoma21 moreThis phase II Pediatric MATCH trial studies how well vemurafenib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations that have spread to other places in the body (advanced) and have come back (recurrent) or do not respond to treatment (refractory). Vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.