Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Edema

Brain Neoplasms

Astrocytoma

Brain Edema

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Chronic Graft Versus Host Disease

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Dexamethasone acetate

BB 1101

Adrenocorticotropic Hormone

Corticotropin-Releasing Hormone

Hormones

Hormone Antagonists

Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.

Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking

hCRF ; open-label dexamethasone that the patient is currently taking

hCRF

placebo hCRF 2mg/day and open-label dexamethasone that they are taking

placebo hCRF

William Shapiro, MD

The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms.

XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.

XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors

A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone

The primary efficacy endpoint was the proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Week 5. Responders were defined as study patients who demonstrated the following:

* 50% or greater reduction in dexamethasone dose relative to Baseline
* Overall 10-Item Neurological Examination Score unchanged or lower compared to Baseline
* Karnofsky Score unchanged or increased relative to Baseline

• The proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Weeks 5 and 8.

Change from Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week follow-up visit). Each item is scored from 0 (normal) to 4 (severely abnormal) except for speech (0-3) for a total range of 0-39. Total score for each patient was the sum of each item score. Change is calculated as the follow-up score minus the baseline score; a negative value indicates improvement.

Change from Baseline in the Karnofsky Performance Score at Weeks 2, 5, 8, 12 and 16.The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death. Although practitioners occasionally assign performance scores in between standard intervals of 10 as follows:

100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs.

50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.

20 - Very sick; hospital admission necessary; active supportive treatment nec

The FACT-Br Quality of Life Questionnaire was self-administered at Baseline, Weeks 5 and 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up).FACT-Br is a reliable and valid 50-item measure that includes FACT-G (27 items) and a brain subscale (23 items) to assess health-related quality of life in brain tumor patients. Each inventory question is scored from 0 (worst possible QOL) to 4 (best possible QOL)

Myopathy, using Kendall Myopathy Scale, was assessed at Baseline, Week 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up). The Kendall Myopathy Scale is a 10 point scale where 10 represents holding test position against strong pressure (best) and 0 represents no contraction palpable (worst).

The maximum reduction in dexamethasone usage at any time during the study. Dexamethasone dosage was assessed at Weeks 0, 2, 5, 8, 12 and 16.

Numbers of patients who discontinued prior to the Week 5 assessment

Neurobiological Technologies

Celtic Pharma Development Services

Treatment-emergent adverse events (TEAEs) excluded steroid-related conditions noted on the medical history. One patient was randomized to placebo but was administered hCRF instead. For the assessment of safety, the patient data has been included based on the treatment administered rather than that originally randomized.

Placebo

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Canada

Australia

New Zealand

Region of Enrollment

Patrick O'Connor, MD, Managing Director Clinical Development

The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5

Percent of Patients in Each Treatment Group Achieving 50% Reduction in Dexamethasone Usage Relative to Baseline by Week 2 Without Deterioration in Neurological Function as Measured by the 10-Item Neurological Exam and the KPS

Week 2

Week 5

Week 8

The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Who Continue to be Responders at Weeks 5 and 8

Week 12

Last Visit

Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation)

Change From Baseline in the Karnofsky Performance Score

Week 16

Change From Baseline in the FACT-Br Quality of Life Results

Change From Baseline in Myopathy Assessment Results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up Visit)

Intent to Treat population; baseline observation carried forward

Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study

Number of Patients Who Discontinued Study Drug Prior to the End of Week 5

Overall Study

Heart and Blood Diseases

Wounds and Injuries

Hemorrhage

Stroke

Hypertension

Intracranial Hypertension

Brain Injuries

Brain Injuries, Traumatic

Cerebral Hemorrhage

Craniocerebral Trauma

Trauma, Nervous System

Cerebrovascular Disorders

Vascular Diseases

Intracranial Hemorrhages

Acute Graft Versus Host Disease

Dynamic decompressive craniotomy with semi-rigid bone flap fixation

Dynamic craniotomy

Prospective observational study on patients undergoing decompressive craniotomy

A prospective study of 20 neurosurgical patients evaluating the dynamic decompressive craniotomy technique using NeuroVention, LLC craniotomy bone flap fixation plates. The plates allow for rigid and semi-rigid bone flap fixation dependent on the implantation technique. A dynamic craniotomy involves bone flap fixation wherein a limited transient outward bone flap movement is allowed by the plates to compensate for an increase in intracranial pressure from brain swelling. The plates also prevent the craniotomy bone flap from sinking inside the skull and compressing on the brain. Cerebral decompression surgery is undertaken for patients with cerebral swelling from malignant strokes, medically intractable intracranial pressure elevation in traumatic brain injuries and brain tumors. The dynamic craniotomy technique eliminates or reduces the need for a cranioplasty surgery with a potentially significant improvement in outcome.

Dynamic Decompressive Craniotomy

Modified Rankin Scale and Glasgow Outcome Score

CT scan to assess rate of normal bone flap position

Halifax Health

Rohit Khanna, MD

Principal Investigator

Glioma

Antirheumatic Agents

Analgesics

Chrysarobin

The patients will receive fluid therapy under goal directed.

The patients will receive routine fluid therapy.

Target parameter will be titrated with fluid bolus, and thus individual amount varied depending on the parameter value at that time. Maintenance of oxygenation, hemoglobin, blood glucose, core temperature and hemodynamics, such as mean arterial pressure and heart rate, will be applied according to the same standard for each patient.

GDFT

Fluid therapy will be done without goal directed. Maintenance of oxygenation, hemoglobin, blood glucose, core temperature and hemodynamics, such as mean arterial pressure and heart rate, will be applied according to the same standard for each patient.

traditional fluid therapy

Whether a fluid protocol aiming for protecting vital organ perfusion or fluid restriction is favorable to post-craniotomy outcomes such as brain edema remains uncertain. To our knowledge, there has been no extensive and quantitative analysis of brain edema following SVV-based GDFT in neurosurgical patients with malignant supratentorial glioma. So the study aims to observe the effect of the stroke volume variation-based GDFT on the postoperative brain edema and decrease the incidence of postoperative complications in neurosurgical patients with malignant supratentorial gliomas.

Effects of Intraoperative GDFT on the Postoperative Brain Edema

Effects of Intraoperative Goal-directed Fluid Therapy (GDFT) on the Postoperative Brain Edema in Neurosurgical Patients With Malignant Supratentorial Gliomas

Postoperative brain edema is defined as edema surrounding the surgical resection cavity, which will be evaluated through CT images.Image evaluators will manually delineate region of interest (ROI) and operative cavity on each slice. The area will be calculated automatically by PACS system. The total volume will be acquired by multiplying area and slice thickness. The volume of edema will be calculated by the totoal volume of edema plus cavity minus the volume of cavity.

Delirium was assessed twice daily (between 8-10 am and between 6-8 pm) with the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for critical care patients, or the 3-minute Diagnostic interview for Confusion Assessment Method (3D-CAM) for ward assessments, combined with the Richmond Agitation Sedation Scale (RASS). Delirium assessments were only conducted in patients with RASS sedation score exceeding -4.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors	NCT00088166	Brain Edema Brain Tumor	hCRF placebo hCRF	18 Years -	Celtic Pharma Development Services
Dynamic Decompressive Craniotomy	NCT05051488	Brain Edema TBI (Traumatic ... Stroke, Acute Cerebral Hemorr... Brain Tumor	Dynamic craniot... Dynamic craniot...	18 Years -	NeuroVention, LLC
Effects of Intraoperative GDFT on the Postoperative Brain Edema	NCT03323580	Fluid Therapy Brain Edema Brain Tumor	GDFT traditional flu...	18 Years - 65 Years	Beijing Tiantan Hospital
XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors	NCT00088166	Brain Edema Brain Tumor	hCRF placebo hCRF	18 Years -	Celtic Pharma Development Services

Spots Global Cancer Trial Database for brain edema

Every month we try and update this database with for brain edema 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 brain edema

Every month we try and update this database with for brain edema 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 brain edema 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.