Neoplasms

All Conditions

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Newly diagnosed patients will be referred to a palliative care provider in the clinic for initial consultation and follow-up during their initial treatment for WHO Grade IV malignant glioma. Patients will be asked to complete a number of questionnaires and assessment forms at different time intervals during the course of their initial treatment. In addition, we will ask patients' neuro-oncology providers for feedback regarding their satisfaction with the Palliative Care services provided to the patient.

Initial consultation and follow-up with a palliative care provider

Palliative Care

Katherine Peters, MD, PhD

David Casarett, MD, MA

The purpose of this research study is to determine the feasibility and acceptability of incorporating palliative care into the clinical care plans of patients newly diagnosed with malignant brain tumors. Palliative Care is a field of medicine that focuses on providing relief from symptoms and stress related to serious illnesses. This study will assess the feasibility of conducting a future study, and will gather data upon which to appropriately tailor the intervention and the future study design. The statistical analysis of this study will describe 8 components that encompass each of the 4 areas of focus or "domains": acceptability, demand, implementation, and integration.

Patients who agree to participate at their initial consultation in our clinic will receive a referral to a Palliative Care (PC) provider who is also located in our clinic and an initial appointment will be scheduled with the PC provider. The frequency of follow-up visits with the PC provider will be at the discretion of the PC provider and the patient. Visits with the PC and neuro-oncology providers will be scheduled on the same day whenever possible. As part of the study, participants will be asked to complete a number of questionnaires and assessment forms at different time intervals. These questionnaires and assessments are intended to track symptoms experienced during the course of treatment. Total study duration is about nine months.

Patients newly diagnosed with World Health Organization (WHO) Grade IV malignant glioma will be referred to a Palliative Care provider in the clinic, in order to assess the impact of early palliative care intervention.

Early Palliative Care Intervention in Malignant Glioma

Model of Early Palliative Care Intervention in Patients With Newly Diagnosed WHO Grade IV Malignant Glioma, a Single Arm Feasibility Study

Mean scores obtained from patient-completed FAMCARE-P16 questionnaires. The FAMCARE-P16 measures patient satisfaction using 16 items on a Likert scale which are summed together to produce an aggregate score of satisfaction. It will be administered at study completion or when a patient is discharged to hospice or withdraws study participation.

The percentage of providers who respond "Always" or "Most of the time" to the question "Were you satisfied with your patient's care are the palliative care clinic?" among those providers who complete the Palliative Care Clinic (PCC) Referring Provider Satisfaction Survey upon each patient's study completion.

The percentage of patients who continue to follow up with their palliative care provider after initial consultation among those who receive initial consultation.

The percentage of patients who respond "Yes" to the question "Do you plan to continue to see a palliative care provider after your participation on the study is complete?" among those who complete the end of study questionnaires. This question will be included in the questionnaires administered at study completion.

The difference in months between the date the first patient is enrolled and the date the 50th patient is enrolled.

The percentage of patients who choose to enroll in the study among those to which the study is offered.

The percentage of patients who complete all study-related questionnaires and procedures among those enrolled.

The percentage of providers who respond "Yes" or "Yes with modification" to the question "Do you think that this model of early palliative care referral is feasible to integrate into the existing clinical infrastructure in your outpatient oncology clinic?" among those providers who complete the PCC Referring Provider Satisfaction Survey upon each patient's study completion.

Duke Cancer Institute

Duke University

Behaviors and Mental Disorders

Glioblastoma

Astrocytoma

Quality of Life

Patients diagnosed with WHO Grade IV malignant glioma who are approved and planned to use the NovoTTF device

We are studying the effect of Tumor Treating Fields (NovoTTF), for example Optune™, on the quality of life, including exercise, sleep quality, and mood, of patients with malignant glioma who plan to use the NovoTTF device.

NovoTTF

Katherine B Peters, MD, PhD

This purpose of this study is to describe the effect of Tumor Treating Fields (NovoTTF) on quality of life (QOL), including exercise, sleep quality, and mood, in patients with World Health Organization (WHO) Grade IV malignant glioma who have been prescribed and approved to receive Optune™. This is an observational, longitudinal study, meaning that information about QOL will be collected over time while the patient is using the NovoTTF device (for example, Optune™).

Patients will be provided with a Fitbit Charge HR™, which they will begin wearing immediately to collect baseline information. The study team will teach the patients how to use the Fitbit and the associated smart phone application. Patients will also set an account with a platform that will provide information from the Fitbit (number of steps, sleep behaviors, and exercise log) to the study team. Patients will also have blood drawn, do a 6-minute walk test, and complete questionnaires at clinic visits 1, 8, 16, and 24 weeks after receiving the Fitbit. At the end of the study, patients will return the Fitbit to the study team.

Quality of Life of Patients With Glioblastoma (GBM) Treated With Tumor-Treating Fields

ACTION: A Longitudinal Observational Study of Quality of Life, Functional Capacity and Physical Function in Glioblastoma Patients Treated With Tumor-Treating Fields

Mean change between baseline and week 24 in total physical activity (MET-h/wk) as measured by the Godin Leisure Time Questionnaire

Mean change from baseline at week 24 in subscales of the Functional Assessment of Cancer Therapy Brain (FACT-Br) and Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F)

Mean change from baseline at week 24 in sleep quality as measured by the Pittsburgh Sleep Quality Assessment (PSQI)

Mean change from baseline at week 24 in mood as measured by the Beck Depression Inventory (BDI)

Mean change from baseline at week 24 in functional capacity as measured by the 6-minute walk test

Mean change from baseline at week 8, 16, and 24 in the average daily number of steps as measured by the Fitbit among patients treated with Novo TTF

NovoCure Ltd.

Nervous System Diseases

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Brain Neoplasms

Neoplasm Metastasis

Lung Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

All patients will be instructed to report pre-defined, non-life-threatening cognitive symptoms as often as relevant through the Noona® application for 17 weeks.

Erin Severance

This study represents a survivorship protocol that focuses on cognition and health-related quality of life (HRQoL) in cancer patients that have received prior brain irradiation. The primary purpose of this study is to assess the feasibility of using a digital symptom tracking application focused on HRQoL and cognition in cancer survivors who received brain irradiation.

Patients who may participate in the study are cancer survivors who received cranial irradiation for conditions including, but not limited to: primary brain tumors, brain metastases, patients with lung cancer receiving prophylactic brain irradiation, and long-term survivors of pediatric cancers. Patients will use the Noona® Healthcare Mobile PRO Application to identify real time select HRQoL and cognitive symptoms. Patients will be instructed to log symptoms as often as relevant using their own personal devices, as well as be prompted to fill out the Patient-Reported Outcomes Measurement Information System Global Health Screen (PROMIS Global Health-10 and Edmonton Symptom Assessment Scale) during treatment (weeks 9 and 14). Patient engagement with the application will be tracked to determine feasibility.

Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy

Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy: Focus on Health-Related Quality of Life and Cognition

The percentage of patients returning for their Week 15 clinic appointment who initiate PROMIS and ESAS questionnaires via the mobile application at Week 14

Varian Medical Systems

Recurrence

All Drugs and Chemicals

Vaccines

Immunomodulating Agents

Patients will receive vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids) intramuscularly into the deltoid muscle. Patients will then receive vorasidenib 40mg orally once a day for 28 days. After two cycles of 28-day vorasidenib and at the start of the 3rd cycle of vorasidenib, patients will receive the PEPIDH1M vaccine intradermally (i.d.) to alternating groin regions on the following schedule: vaccine #1, day 1; vaccine #2, day 15. The day before vaccine #1, patients will receive a vaccine site pre-conditioning injection of a single dose of Td toxoid. This will be administered twelve hours to one day prior to receiving PEPIDH1M vaccine i.d. to the RIGHT groin area. Vaccines #3 and #4 will be given on day 1 and day 15 of cycle 4. Starting on 6th cycle of 28-day vorasidenib, subjects will receive PEPIDH1M vaccine (i.d. to alternating groin regions) every 28 days on day 1 for vaccine #5-#12. Patients will receive up to a total of 14 cycles of vorasidenib.

PEPIDH1M vaccine + vorasidenib

Stevie Threatt

The purpose of this study is to determine the safety and efficacy of a PEPIDH1M vaccine in combination with vorasidenib, a dual inhibitor of mutant IDH1 and IDH2 enzymes, in adult patients diagnosed with recurrent IDH1 mutant lower grade gliomas.

This study is designed to assess the safety and efficacy of the PEPIDH1M vaccine in combination with vorasidenib in adult patients recurrent IDH1 mutant lower grade gliomas. Patients will receive vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly (I.M.) into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Patients will then receive vorasidenib 40 mg orally once a day for 28 days. After two cycles of 28-day vorasidenib and at the start of the 3rd cycle of vorasidenib, patients will receive the PEPIDH1M vaccine intradermally (i.d.) to alternating groin regions on the following schedule: vaccine #1, day 1; vaccine #2, day 15. The day before vaccine #1, patients will receive a vaccine site pre-conditioning injection of a single dose of Td toxoid (1 flocculation unit \[Lf\] in a total volume of 0.4 mL saline). This will be administered twelve hours to one day prior to receiving PEPIDH1M vaccine i.d. to the RIGHT groin area. Vaccines #3 and #4 will be given on day 1 and day 15 of cycle 4. Starting on 6th cycle of 28-day vorasidenib, subjects will receive PEPIDH1M vaccine (i.d. to alternating groin regions) every 28 days on day 1 for vaccine #5-#12. Patients will receive up to a total of 14 cycles of vorasidenib. Notably, a safety lead-in will be performed before commencing on the full study to assess the safety of the combination and evaluation for any dose-limiting toxicity (DLT).

The most common side effects of peptide vaccines are redness or swelling at the injection site, local changes to the texture of skin (hardening) at the injection site, itching, allergic reactions, and a potentially serious side effect called cytokine release syndrome. The most common side effects of vorasidenib are abnormal liver function tests, QT prolongation, stomach and/or intestinal ulcers, neurologic disturbances, skin peeling, and isocitrate dehydrogenase (IDH) differentiation syndrome.

All patients who receive any protocol treatment will be included in either primary or secondary efficacy analyses. Statistical analyses for the primary objective of adverse experience will exclude patients who terminate protocol treatment prematurely (i.e., less than 4 vaccinations) without an unacceptable toxicity.

ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas

The proportion of patients with an unacceptable toxicity

The time between initiation of cycle 1 vorasidenib and first documentation of disease progression or death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Palliative Care Intervention in Malignant Glioma	NCT03471546	Malignant Gliom...	Palliative Care	18 Years -	Duke University
Quality of Life of Patients With Glioblastoma (GBM) Treated With Tumor-Treating Fields	NCT03501134	Malignant Gliom...	NovoTTF	18 Years -	Duke University
Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy	NCT04567251	Brain Metastase... Primary Brain T... Lung Cancer		18 Years -	Duke University
Early Palliative Care Intervention in Malignant Glioma	NCT03471546	Malignant Gliom...	Palliative Care	18 Years -	Duke University
ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas	NCT05609994	Low Grade Gliom...	PEPIDH1M vaccin...	18 Years -	Duke University
Early Palliative Care Intervention in Malignant Glioma	NCT03471546	Malignant Gliom...	Palliative Care	18 Years -	Duke University
ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas	NCT05609994	Low Grade Gliom...	PEPIDH1M vaccin...	18 Years -	Duke University

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