scholarly journals Severe cerebral edema following nivolumab treatment for pediatric glioblastoma: case report

2017 ◽  
Vol 19 (2) ◽  
pp. 249-253 ◽  
Author(s):  
Xiao Zhu ◽  
Michael M. McDowell ◽  
William C. Newman ◽  
Gary E. Mason ◽  
Stephanie Greene ◽  
...  
Keyword(s):  
Cerebral Edema ◽  
Tumor Necrosis ◽  
Phase Iii ◽  
Do Not Resuscitate ◽  
Midline Shift ◽  
Decompressive Hemicraniectomy ◽  
Phase Iii Clinical Trials ◽  
First Case ◽  
Immune Mediated ◽  
Left Pupil

Nivolumab is an immune checkpoint inhibitor (ICI) currently undergoing Phase III clinical trials for the treatment of glioblastoma. The authors present the case of a 10-year-old girl with glioblastoma treated with nivolumab under compassionate-use guidelines. After the first dose of nivolumab the patient developed hemiparesis, cerebral edema, and significant midline shift due to severe tumor necrosis. She was managed using intravenous dexamethasone and discharged on a dexamethasone taper. The patient's condition rapidly deteriorated after the second dose of nivolumab, demonstrating hemiplegia, seizures, and eventually unresponsiveness with a fixed and dilated left pupil. Computed tomography of her brain revealed malignant cerebral edema requiring emergency decompressive hemicraniectomy. Repeat imaging demonstrated increased size of the lesion, reflecting immune-mediated inflammation and tumor necrosis. The patient remained densely hemiplegic, but became progressively more interactive and was ultimately extubated. She resumed nivolumab several weeks later, but again her condition deteriorated with headache, vomiting, swelling at the craniectomy site, and limited right-sided facial movement following the sixth dose. MRI demonstrated severe midline shift and uncal herniation despite her craniectomy. Her condition gradually declined, and she died several days later under “do not resuscitate/do not intubate” orders. To the authors' knowledge, this represents the first case of malignant cerebral edema requiring operative intervention following nivolumab treatment for glioblastoma in a pediatric patient.

scholarly journals Late Onset Ipilimumab-Induced Pericarditis and Pericardial Effusion: A Rare but Life Threatening Complication

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Seongseok Yun ◽  
Nicole D. Vincelette ◽  
Iyad Mansour ◽  
Dana Hariri ◽  
Sara Motamed
Keyword(s):  
T Cell ◽  
T Cell Activation ◽  
Cutaneous Melanoma ◽  
Cell Activation ◽  
Cytotoxic T Lymphocyte ◽  
Late Onset ◽  
Human Monoclonal Antibody ◽  
Phase Iii ◽  
First Case ◽  
Immune Mediated

Metastatic cutaneous melanoma has poor prognosis with 2-year survival rate of 10–20%. Melanoma cells express various antigens including gp100, melanoma antigen recognized by T cells 1 (MART-1), and tyrosinase, which can induce immune-mediated anticancer response via T cell activation. Cytotoxic T-lymphocyte associated antigen-4 (CTLA-4) is an immune check point molecule that negatively regulates T cell activation and proliferation. Accordingly, recent phase III clinical trials demonstrated significant survival benefit with ipilimumab, a human monoclonal antibody (IgG1) that blocks the interaction of CTLA-4 with its ligands. Since the efficacy of ipilimumab depends on T cell activation, it is associated with substantial risk of immune mediated adverse reactions such as colitis, hepatitis, thyroiditis, and hypophysitis. We report the first case of late onset pericarditis and cardiac tamponade associated with ipilimumab treatment in patient with metastatic cutaneous melanoma.

scholarly journals A Web Based Dynamic MANA Nomogram for Predicting the Malignant Cerebral Edema in patients with large hemispheric infarction

2020 ◽  
Author(s):  
Wenzhe Sun ◽  
Guo Li ◽  
Yang Song ◽  
Zhou Zhu ◽  
Zhaoxia Yang ◽  
...  
Keyword(s):  
Cerebral Edema ◽  
Clinical Decision Making ◽  
Mass Effect ◽  
Clinical Decision ◽  
Chinese Patients ◽  
Midline Shift ◽  
Patient Death ◽  
Exact Probability ◽  
Decompressive Hemicraniectomy ◽  
Hemispheric Infarction

Abstract Background: For large hemispheric infarction (LHI), malignant cerebral edema (MCE) is a life-threatening complication with a mortality rate approaching 80%. Establishing a convenient prediction model of MCE after LHI is vital for the rapid identification of high-risk patients as well as for a better understanding of the potential mechanism underlying MCE.Methods: 142 consecutive patients with LHI within 24h of onset between January 1, 2016 and August 31, 2019 were retrospectively reviewed. MCE was defined as patient death or received decompressive hemicraniectomy (DHC) with obvious mass effect (≥ 5mm midline shift or Basal cistern effacement). Binary logistic regression was performed to identify independent predictors of MCE. Independent prognostic factors were incorporated to build a dynamic nomogram for MCE prediction.Results: After adjusting for confounders, four independent factors were identified, including previously known atrial fibrillation (KAF), midline shift (MLS), National Institutes of Health Stroke Scale (NIHSS) and anterior cerebral artery (ACA) territory involvement. To facilitate the nomogram use for clinicians, we used the “Dynnom” package to build a dynamic MANA (acronym for MLS, ACA territory involvement, NIHSS and KAF) nomogram on web (http://www.MANA-nom.com) to calculate the exact probability of developing MCE. The MANA nomogram’s C-statistic was up to 0.887 ± 0.041 and the AUC-ROC value in this cohort was 0.887 (95%CI, 0.828~0.934).Conclusions: Independent MCE predictors included KAF, MLS, NIHSS, and ACA territory involvement. The dynamic MANA nomogram is a convenient, practical and effective clinical decision-making tool for predicting MCE after LHI in Chinese patients.

scholarly journals A Web Based Dynamic MANA Nomogram for Predicting the Malignant Cerebral Edema in patients with large hemispheric infarction

2020 ◽  
Author(s):  
Wenzhe Sun ◽  
Guo Li ◽  
Yang Song ◽  
Zhou Zhu ◽  
Zhaoxia Yang ◽  
...  
Keyword(s):  
Cerebral Edema ◽  
Clinical Decision Making ◽  
Mass Effect ◽  
Clinical Decision ◽  
Chinese Patients ◽  
Midline Shift ◽  
Patient Death ◽  
Exact Probability ◽  
Decompressive Hemicraniectomy ◽  
Hemispheric Infarction

Abstract Background: For large hemispheric infarction (LHI), malignant cerebral edema (MCE) is a life-threatening complication with a mortality rate approaching 80%. Establishing a convenient prediction model of MCE after LHI is vital for the rapid identification of high-risk patients as well as for a better understanding of the potential mechanism underlying MCE. Methods: 142 consecutive patients with LHI within 24h of onset from January 1, 2016 to August 31, 2019 were retrospectively collected. MCE was defined as patient death or received decompressive hemicraniectomy (DHC) with obvious mass effect (≥ 5mm midline shift or Basal cistern effacement). Binary logistic regression was performed to identify independent predictors of MCE. Independent prognostic factors were incorporated to build a dynamic nomogram for MCE prediction. Results : After adjustment for confounders, four independent factors were identified, including previously known atrial fibrillation (KAF), midline shift (MLS), National Institutes of Health Stroke Scale (NIHSS) and anterior cerebral artery (ACA) territory involvement. To facilitate the use of nomogram for clinicians, we use “Dynnom” package to build dynamic MANA (acronym for MLS, ACA territory involvement, NIHSS and KAF) nomogram on web page ( http://www.MANA-nom.com ) to calculate the exact probability of developing MCE. The c-statistic of MANA nomogram was up to 0.887 ± 0.041 and AUC-ROC value in this cohort was 0.887 (95%CI, 0.828~0.934). Conclusions: Independent predictors of MCE included KAF, MLS, NIHSS, and ACA territory involvement. The dynamic MANA nomogram is a convenient, practical and effective clinical decision-making tool for predicting MCE after LHI in Chinese patients.

scholarly journals A web based dynamic MANA Nomogram for predicting the malignant cerebral edema in patients with large hemispheric infarction

BMC Neurology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Wenzhe Sun ◽  
Guo Li ◽  
Yang Song ◽  
Zhou Zhu ◽  
Zhaoxia Yang ◽  
...  
Keyword(s):  
Cerebral Edema ◽  
Clinical Decision Making ◽  
Mass Effect ◽  
Clinical Decision ◽  
Chinese Patients ◽  
Midline Shift ◽  
Patient Death ◽  
Exact Probability ◽  
Decompressive Hemicraniectomy ◽  
Hemispheric Infarction

Abstract Background For large hemispheric infarction (LHI), malignant cerebral edema (MCE) is a life-threatening complication with a mortality rate approaching 80%. Establishing a convenient prediction model of MCE after LHI is vital for the rapid identification of high-risk patients as well as for a better understanding of the potential mechanism underlying MCE. Methods One hundred forty-two consecutive patients with LHI within 24 h of onset between January 1, 2016 and August 31, 2019 were retrospectively reviewed. MCE was defined as patient death or received decompressive hemicraniectomy (DHC) with obvious mass effect (≥ 5 mm midline shift or Basal cistern effacement). Binary logistic regression was performed to identify independent predictors of MCE. Independent prognostic factors were incorporated to build a dynamic nomogram for MCE prediction. Results After adjusting for confounders, four independent factors were identified, including previously known atrial fibrillation (KAF), midline shift (MLS), National Institutes of Health Stroke Scale (NIHSS) and anterior cerebral artery (ACA) territory involvement. To facilitate the nomogram use for clinicians, we used the “Dynnom” package to build a dynamic MANA (acronym for MLS, ACA territory involvement, NIHSS and KAF) nomogram on web (http://www.MANA-nom.com) to calculate the exact probability of developing MCE. The MANA nomogram’s C-statistic was up to 0.887 ± 0.041 and the AUC-ROC value in this cohort was 0.887 (95%CI, 0.828 ~ 0.934). Conclusions Independent MCE predictors included KAF, MLS, NIHSS, and ACA territory involvement. The dynamic MANA nomogram is a convenient, practical and effective clinical decision-making tool for predicting MCE after LHI in Chinese patients.

Biosimilars

Lupus ◽  
2020 ◽  
Vol 29 (6) ◽  
pp. 525-532
Author(s):  
Christopher J Edwards ◽  
Salvatore Bellinvia
Keyword(s):  
Lupus Erythematosus ◽  
Inflammatory Diseases ◽  
Treatment Options ◽  
Mechanisms Of Action ◽  
Phase Iii ◽  
Biological Therapies ◽  
Systemic Lupus ◽  
Safety And Efficacy ◽  
Phase Iii Clinical Trials ◽  
Immune Mediated

Biological therapies have widened the therapeutic armamentarium for immune-mediated inflammatory diseases, providing in many cases a broad range of treatment options with different mechanisms of action. The widespread use of biological agents in systemic lupus erythematosus is currently limited to belimumab and rituximab, although results of promising larger Phase III clinical trials are awaited or have been recently circulated, especially for anti-cytokine therapies. The loss of exclusivity over the last years for several originator biologics has started the successful introduction of biosimilar products into clinical practice. There is an abbreviated pathway to biosimilar approval, but this is underpinned by the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. Nevertheless, there are unique reasons why development of biosimilars may be particularly challenging in lupus.

scholarly journals A Web Based Dynamic MANA Nomogram for Predicting the Malignant Cerebral Edema in patients with large hemispheric infarction

2020 ◽  
Author(s):  
Wenzhe Sun ◽  
Guo Li ◽  
Yang Song ◽  
Zhou Zhu ◽  
Zhaoxia Yang ◽  
...  
Keyword(s):  
Cerebral Edema ◽  
Clinical Decision Making ◽  
Mass Effect ◽  
Clinical Decision ◽  
Chinese Patients ◽  
Midline Shift ◽  
Patient Death ◽  
Exact Probability ◽  
Decompressive Hemicraniectomy ◽  
Hemispheric Infarction

Abstract Background: For large hemispheric infarction (LHI), malignant cerebral edema (MCE) is a life-threatening complication with a mortality rate approaching 80%. Establishing a convenient prediction model of MCE after LHI is vital for the rapid identification of high-risk patients as well as for a better understanding of the potential mechanism underlying MCE.Methods: 142 consecutive patients with LHI within 24h of onset from January 1, 2016 to August 31, 2019 were retrospectively collected. MCE was defined as patient death or received decompressive hemicraniectomy (DHC) with obvious mass effect (≥ 5mm midline shift or Basal cistern effacement). Binary logistic regression was performed to identify independent predictors of MCE. Independent prognostic factors were incorporated to build a dynamic nomogram for MCE prediction. Results: After adjustment for confounders, four independent factors were identified, including previously known atrial fibrillation (KAF), midline shift (MLS), National Institutes of Health Stroke Scale (NIHSS) and anterior cerebral artery (ACA) territory involvement. To facilitate the use of nomogram for clinicians, we use “Dynnom” package to build dynamic MANA (acronym for MLS, ACA territory involvement, NIHSS and KAF) nomogram on web page (http://www.MANA-nom.com) to calculate the exact probability of developing MCE. The c-statistic of MANA nomogram was up to 0.887 ± 0.041 and AUC-ROC value in this cohort was 0.887 (95%CI, 0.828~0.934).Conclusions: Independent predictors of MCE included KAF, MLS, NIHSS, and ACA territory involvement. The dynamic MANA nomogram is a convenient, practical and effective clinical decision-making tool for predicting MCE after LHI in Chinese patients.

Rome I versus Rome II; Overlap in patients enrolled in tegaserod phase III clinical trials for irritable bowel syndrome (IBS)

2001 ◽  
Vol 120 (5) ◽  
pp. A284-A284
Author(s):  
B NAULT ◽  
S SUE ◽  
J HEGGLAND ◽  
S GOHARI ◽  
G LIGOZIO ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Irritable Bowel Syndrome ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Irritable Bowel ◽  
Rome I

Neovastat, a naturally occurring multifunctional antiangiogenic drug, in phase III clinical trials

2001 ◽  
Vol 28 (6) ◽  
pp. 620-625 ◽  
Author(s):  
Pierre Falardeau ◽  
Pierre Champagne ◽  
Patrick Poyet ◽  
Claude Hariton ◽  
[Eacute]ric Dupont
Keyword(s):  
Clinical Trials ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Naturally Occurring ◽  
Antiangiogenic Drug

scholarly journals Animal and Human Vaccines against West Nile Virus

Pathogens ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. 1073
Author(s):  
Juan-Carlos Saiz
Keyword(s):  
Clinical Trials ◽  
West Nile Virus ◽  
Vaccine Development ◽  
Phase Iii ◽  
West Nile ◽  
Specific Therapy ◽  
Phase Iii Clinical Trials ◽  
Neuroinvasive Disease ◽  
The Us ◽  
The Status

West Nile virus (WNV) is a widely distributed enveloped flavivirus transmitted by mosquitoes, which main hosts are birds. The virus sporadically infects equids and humans with serious economic and health consequences, as infected individuals can develop a severe neuroinvasive disease that can even lead to death. Nowadays, no WNV-specific therapy is available and vaccines are only licensed for use in horses but not for humans. While several methodologies for WNV vaccine development have been successfully applied and have contributed to significantly reducing its incidence in horses in the US, none have progressed to phase III clinical trials in humans. This review addresses the status of WNV vaccines for horses, birds, and humans, summarizing and discussing the challenges they face for their clinical advance and their introduction to the market.

Sign in / Sign up

Export Citation Format

Share Document