Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Glioblastoma

Glioma

Brain Neoplasms

Disease Attributes

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Photosensitizing Agents

Fluorescent substance to help visualize and remove as much tumor as possible without harming healthy tissue.

20 mg/kg administered once 3-5 hours prior to surgery

5-ALA (Gliolan)

Costas Hadjipanayis, MD, PhD

The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When the investigators remove the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red under blue light. This may make it easier for your doctor to take out all of the tumor from your brain. The purpose of this study is to:

* Make sure that 5-ALA helps the doctor remove more of the tumor.
* Make sure 5-ALA does not cause any side effects.

If you do not want to participate in this study, your doctor(s) will still do their best to remove all of the tumor in your brain. Whether or not you join this study will not change your treatment for your brain tumor.

More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery

A Multicenter Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas

NX PharmaGen

National Cancer Institute (NCI)

Constantinos Hadjipanayis

Professor and Chair, Neurosurgery

Edema

Brain Edema

Adrenocorticotropic Hormone

Corticotropin-Releasing Hormone

Xerecept

This is a phase II, multicenter, open-label, imaging study of hCRF in the reduction of PBE in patients with primary malignant or metastatic brain tumors. Approximately 30 to 60 patients will be assigned to 1 of 3 treatment groups and receive study drug for up to 28 days

The purpose of this study is to investigate the effect of 3 different regimens of subcutaneous (SC) administered hCRF (1.0 mg every \[Q\] 8 hours \[h\], 1.5 mg Q12h, and 1.0 mg Q12h) on the reduction of PBE in patients with primary malignant or metastatic brain tumors as defined by MRI indexes.

Imaging Study of XERECEPT® Treatment for Peritumoral Brain Edema (PBE)

Open-Label, Imaging Study of Human Corticotropin-Releasing Factor (hCRF) for The Reduction of Peritumoral Brain Edema (PBE) in Patients With Primary Malignant or Metastatic Brain Tumors

Celtic Pharma Development Services

PharmaNet

Pharmanet

Newly diagnosis arm (N=150): The study aims to obtain clinical information to correlate with genetic characterization of ATDGs of all types. Only patients with primary tumors that have recently received surgery are applicable.

Post treatment arm 1 for training set (IDH-wild type ATDGs, N=50; IDH-mutant ATDGs, N=50): The study aims to compare the genetic differences of ATDGs in terms of IDH mutation status. Samples of primary tumors are preferred but can be replaced with recurrent ones. Paired samples are both eligible for typing if the recurrent diseases of IDH-mutant tumors possess potential altered genes (such as up grading per histology features).

Post treatment arm 2 (recurrent ATDGs; N=25): The study will focus on recurrent diseases of ATDGs to study the consistency of genetic difference of the primary and the recurrent tumors. Tumor free is mandatory and needs to be documented after resection of the primary tumor. Patients remain eligible if IDH statuses are uncertain.

A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma

Chien-Ya Hung

Kwang-Yu Chang

Ming-Jung Chuang

Yong-Kwang Tu

Chun-Chung Chen

Chiung-Chyi Shen

E-Jian Lee

Dar-Ming Lai

Yung-Hsiao Chiang

Sanford PC Hsu

kuo-chen wei

Glioma is a major histological subtype of primary malignant brain tumors in Taiwan, with distinct epidemiological, clinical, and pathological features comparing to the other common cancer diseases. The disease rarely appears with metastatic disease at diagnosis, and with the most malignant subtype, glioblastoma, occurs with preference in mid- to old-age. For decades, primary malignant brain tumors has been known as one of the most desperate disease without successful improvement regarding of the treatment. Surgical resection is the principle for the primary treatment of gliomas. Chemotherapy and radiotherapy are often applied to patients for adjuvant therapy of surgery to pursue the treatment effect. Disappointedly, vast majority of the patients would eventually develop disease recurrence, leaving only limited choice for salvage treatment thereafter. The prognosis of these patients remains desperate, and thus a better understanding of this deadly disease is crucial for finding better therapeutic strategies for these patients.

With demand of molecular characterization in precise diagnosis, we proposed this registry study to explore the impact of the new criteria by applying next-generation sequencing. The specific aims of this project are (1) to establish the tumor genetic and molecular profiles of adult-type diffuse gliomas in Taiwan, (2) to understand the treatment prognosis depending on difference of the genetic and molecular profiles for adult-type diffuse gliomas in Taiwan, and (3) to reveal the evolutionary changes of genetic and molecular features of adult-type diffuse gliomas. The long-term goals of this study are to help implement personalized therapy, to develop novel therapy, and to improve outcomes of patients with adult-type diffuse gliomas. It is also expected to create a platform for data storage and sharing.

1. One H\&E staining slide, and 15-20 tissue slides (5 um thickness) for cancer panel.
2. Details of Tests/Collaborative Test Unit:

   Testing will take place in a certified precision medicine laboratory.
3. Non-tumor Sample (Blood): Fifteen (15) ml of blood will be collected from the participant: 7 ml in EDTA tube (purple top) and 8 ml in Cell-Free DNA blood collection tube.

ACTonco+ACTFusion Biospecimen Retention: Samples With DNA One H\&E staining slide, and 15-20 tissue slides (5 um thickness) for cancer panel.

Details of Tests/Collaborative Test Unit:

Testing will take place in a certified precision medicine laboratory.

Non-tumor Sample (Blood): Seven(7)ml of cell free DNA and Eight (8) ml of blood in EDTA tube will be collected from the participant

National Health Research Institutes, Taiwan

CAU+ (Enhanced Care as Usual) is defined as the care received from the care recipient's oncologist supplemented by unlimited access to three components of the study website: caregiver guides, links to web-based resources, and a basic friends and family page for the 10 month duration of the study.

CAU+ (Enhanced Care as Usual) for eight weeks, followed by eight weeks of SmartCare. SmartCare is a web-based, nurse guided intervention for caregivers based on the Representational Approach of symptom management.

CAU+ (Enhanced Care as Usual) and Beating the Blues concurrently for eight weeks, followed by SmartCare for eight weeks. Beating the Blues is an established, web-based, self-directed, cognitive behavioral therapy for managing depressive symptoms.

CAU+ is defined as the care received from the care recipient's oncologist supplemented by unlimited access to three components of the study website: caregiver guides, links to web-based resources, and a basic friends and family page. These resources are routinely available on the Internet. We provide these as a "one-stop shopping" resource in order to standardize care as usual for caregivers. All caregivers will be sent personalized e-mails from the project director every week during the intervention period.

CAU+ (Enhanced Care as Usual)

Beating the Blues is an established, self-directed, web-based cognitive behavioral therapy program for managing depressive symptoms. Caregivers are asked to complete 8 weekly sessions, each lasting approximately 50 minutes. Participants are also given simple "homework" after each lesson.

Beating the Blues

SmartCare is a web-based, nurse guided intervention for caregivers based on the Representational Approach of symptom management. The RA builds on traditional cognitive-behavioral interventions by promoting in depth reflection of previous and current experiences, beliefs, and knowledge (referred to as representations) prior to providing new information or engaging in problem-solving.

SmartCare

Paula R Sherwood, PhD

Heidi S Donovan, PhD

This is a study to evaluate the effectiveness of using an established intervention for depressive symptom management in conjunction with a needs-based caregiver intervention for improving the psychological and physical health of family caregivers of persons recently diagnosed with a Primary Malignant Brain Tumor.

We have designed a needs-based intervention to improve neuro-oncology caregivers' health. Our novel approach treats depressive symptoms prior to implementing a needs-based intervention in a sample of PMBT family caregivers who score above threshold on depressive symptoms. Study outcomes are psychological responses (unmet needs, depressive symptoms, anxiety, and burden) and physical responses (levels of stimulated and circulating IL-6 and IL-1β, C-reactive protein, peripheral blood mono-nuclear cells, physical symptoms, and new diagnoses or exacerbations of co-morbid conditions). The proposed study addresses research priorities set by both NCI and NINR to improve the quality of life of patients and their families and NINR's emphasis on integrating bio-behavioral science and adopting, adapting and generating new technologies.

Primary aims:

1. Compare the efficacy of a) an intervention for depressive symptoms (Beating the Blues) delivered prior to a needs-based caregiver intervention (SmartCare©) versus b) SmartCare© alone versus c) enhanced care as usual (CAU+) in improving caregivers' psychological and physical responses.

   H1: At 4- and 6-months, caregivers who receive Beating the Blues prior to SmartCare© will display improved psychological and physical responses compared to caregivers who receive CAU+.

   H2: At 4- and 6-months, caregivers who receive SmartCare© alone will display improved psychological and physical responses compared to caregivers who receive CAU+.

   H3: At 4- and 6-months, caregivers who receive Beating the Blues prior to SmartCare© will display improved psychological and physical responses compared to those who receive SmartCare© alone.
2. Compare the efficacy of Beating the Blues versus CAU+ in improving subjects' short-term psychological and physical responses.

H1: At 2-months following baseline, caregivers who receive Beating the Blues will display improved psychological and physical responses compared to CAU+.

Exploratory aims:

1. Determine whether any changes in psychological and physical health resulting from receiving Beating the Blues prior to SmartCare© or SmartCare© alone are maintained at 10-months after baseline.
2. Evaluate whether the effect of Beating the Blues + SmartCare© (vs. SmartCare© alone) on 4- and 6-month psychological and physical responses is mediated by 0- to 2-month changes in depressive symptoms.

SmartCare: Innovations in Caregiving Interventions

Non-identifiable data will be shared with interested parties in agreement with University policy.

Depressive symptoms will be measured using the 10-item shortened version of the Center for Epidemiologic Studies - Depression (CES-D).

Unmet Needs will be measured via the Caregiver Needs Screen (CNS) questionnaire.

Mastery will be measured using the Caregiver Mastery Scale.

Optimism will be measured using the Life Orientation Test.

Spirituality will measured using the Functional Assessment of Chronic Illness Therapy - Sp (FACIT).

Caregiver oversight demand will be measured using the four item Caregiver Vigilance Scale.

Social support will be measured using the Interpersonal Support Evaluation List (ISEL). Subjects rate the availability of three types of social support (appraisal, belonging, and tangible).

Caregiver occupational functioning will be measured by general questions related to employment status and the Work Limitations Questionnaire (WLQ).

Positive aspects of providing care will be measured using the Positive Aspects of Caregiving (PAC) scale.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery	NCT01445691	Benign Neoplasm... Brain Cancer Brain Neoplasms... Brain Neoplasms... Brain Tumor, Pr... Brain Tumor, Re... Brain Tumors Intracranial Ne... Neoplasms, Brai... Neoplasms, Intr... Primary Brain N... Primary Maligna... Primary Maligna... Gliomas Glioblastoma	5-ALA (Gliolan)	18 Years - 80 Years	Icahn School of Medicine at Mount Sinai
Imaging Study of XERECEPT® Treatment for Peritumoral Brain Edema (PBE)	NCT00691522	Peritumoral Bra... PRIMARY MALIGNA...	Xerecept	18 Years - 65 Years	PharmaNet
A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma	NCT05622409	Primary Maligna...	A Taiwanese Onc...	20 Years -	National Health Research Institutes, Taiwan
SmartCare: Innovations in Caregiving Interventions	NCT02058745	Primary Maligna...	CAU+ (Enhanced ... Beating the Blu... SmartCare	21 Years -	University of Pittsburgh
Imaging Study of XERECEPT® Treatment for Peritumoral Brain Edema (PBE)	NCT00691522	Peritumoral Bra... PRIMARY MALIGNA...	Xerecept	18 Years - 65 Years	PharmaNet

Spots Global Cancer Trial Database for primary malignant brain tumors