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Clinical trials for metastatic melanoma

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https://www.readbyqxmd.com/read/27921276/relationship-between-physician-adjudicated-adverse-events-and-patient-reported-health-related-quality-of-life-in-a-phase-ii-clinical-trial-nct01143402-of-patients-with-metastatic-uveal-melanoma
#1
Thomas M Atkinson, Jennifer L Hay, Alexander Shoushtari, Yuelin Li, Daniel J Paucar, Sloane C Smith, Ragini R Kudchadkar, Austin Doyle, Jeffrey A Sosman, Jorge Fernando Quevedo, Mohammed M Milhem, Anthony M Joshua, Gerald P Linette, Thomas F Gajewski, Jose Lutzky, David H Lawson, Christopher D Lao, Patrick J Flynn, Mark R Albertini, Takami Sato, Karl Lewis, Brian Marr, David H Abramson, Mark Andrew Dickson, Gary K Schwartz, Richard D Carvajal
PURPOSE: Clinical trials commonly use physician-adjudicated adverse event (AE) assessment via the common terminology criteria for adverse events (CTCAE) for decision-making. Patient-reported health-related quality of life (HRQoL) data are becoming more frequent in oncology; however, the relationship between physician-adjudicated AE assessment and HRQoL is understudied. METHODS: Data from a phase II trial (clinicaltrials.gov identifier: NCT01143402) where patients with metastatic uveal melanoma were randomized to receive selumetinib, an oral MEK inhibitor, or chemotherapy were analyzed...
December 5, 2016: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/27920706/ipilimumab-induced-enteritis-without-colitis-a-new-challenge
#2
Marcus Messmer, Sunita Upreti, Yaman Tarabishy, Nikhilesh Mazumder, Reezwana Chowdhury, Mark Yarchoan, Matthias Holdhoff
INTRODUCTION: Ipilimumab is an immune checkpoint inhibitor targeting cytotoxic T-lymphocyte associated antigen 4 (CTLA4), approved to treat metastatic melanoma. It was the first therapy shown to prolong survival in a large, randomized clinical trial. However, immune-related adverse events are common and can be severe. Enterocolitis is a common adverse event with ipilimumab, but enteritis without colitis has not been previously described. CASE REPORT: An 83-year-old man presented to our hospital with grade 3 diarrhea for 5 days...
September 2016: Case Reports in Oncology
https://www.readbyqxmd.com/read/27875387/clinical-response-rates-from-interleukin-2-therapy-for-metastatic-melanoma-over-30-years-experience-a-meta-analysis-of-3312-patients
#3
Richard Bright, Brendon J Coventry, Nathan Eardley-Harris, Nancy Briggs
Interleukin-2 (IL-2), initially used in 1986, can induce clinical regression-complete responses (CR) and partial responses (PR) of metastatic malignant melanoma. IL-2 has been used alone or in combination, and in different dosage schedules, as an immunotherapeutic agent for melanoma treatment. This meta-analysis aimed to document and evaluate the spectrum of reported clinical response rates from the combined experience of almost 30 years of IL-2 clinical usage. Clinical trials using IL-2 for metastatic melanoma therapy that reported: dosage, combinations, study details, definitions and clinical CR, PR, and overall response (OR) rates were included...
January 2017: Journal of Immunotherapy
https://www.readbyqxmd.com/read/27864013/factors-predictive-of-response-disease-progression-and-overall-survival-after-dabrafenib-and-trametinib-combination-treatment-a-pooled-analysis-of-individual-patient-data-from-randomised-trials
#4
Georgina V Long, Jean-Jacques Grob, Paul Nathan, Antoni Ribas, Caroline Robert, Dirk Schadendorf, Stephen R Lane, Carmen Mak, Philippe Legenne, Keith T Flaherty, Michael A Davies
BACKGROUND: Dabrafenib plus trametinib treatment provides significant benefits over BRAF-inhibitor monotherapy in patients with BRAF(V600E)-mutant or BRAF(V600K)-mutant advanced melanoma; however, in many patients the disease progresses, leading to death. With many treatment options available, understanding clinical factors that predict long-term response and survival for treatments is important for optimisation of patient management. We aimed to identify clinical factors associated with long-term response and survival using pooled data from randomised trials of dabrafenib plus trametinib in patients with metastatic BRAF-mutant melanoma...
November 15, 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27863085/pharmacokinetics-of-dabrafenib-in-a-patient-with-metastatic-melanoma-undergoing-haemodialysis
#5
John J Park, Alan V Boddy, Xiaoman Liu, David Harris, Vincent Lee, Richard F Kefford, Matteo S Carlino
The combination of dabrafenib and trametinib is a standard of care for the management of BRAF mutant metastatic melanoma. Clinical trials excluded patients with end-stage kidney disease (ESKD) and as such no data are available regarding the safety, efficacy and pharmacokinetics of these drugs in such patients. Here, we present the case of a 78 year-old male patient with ESKD managed with haemodialysis (HD), treated with dabrafenib and trametinib at reduced doses. The patient has had a partial response, and this response continues at 9 months since our last follow up without any dose escalation...
November 10, 2016: Pigment Cell & Melanoma Research
https://www.readbyqxmd.com/read/27843616/update-on-clinical-research-and-state-of-the-art-management-of-patients-with-advanced-sarcomas-and-gist
#6
REVIEW
Yannis Metaxas, Georgios Oikonomopoulos, George Pentheroudakis
Sarcomas constitute a rare group of malignancies. According to histology, different treatment options are effective. For gastrointestinal stromal tumours (GISTs), targeted treatment with imatinib controls about 20% of advanced or metastatic disease, whereas chemotherapy is more effective for the rest of the sarcomas. Currently, new targeted treatments are emerging, showing activity in cases resistant to established primary treatment. On the other hand, the exciting results of immunotherapy for other solid tumours, for example, melanoma and lung cancer, make it a promising option in the fight against sarcomas...
2016: ESMO Open
https://www.readbyqxmd.com/read/27826593/pembrolizumab-therapy-triggering-an-exacerbation-of-preexisting-autoimmune-disease-a-report-of-2-patient-cases
#7
Sneha D Phadke, Ramez Ghabour, Brian L Swick, Andrea Swenson, Mohammed Milhem, Yousef Zakharia
Historically, metastatic melanoma was uniformly and rapidly lethal, and treatment options were limited. In recent years, however, checkpoint inhibitors have emerged as an accepted standard treatment for patients with advanced melanoma. In clinical trials, these agents have been largely well tolerated and have the potential to result in durable responses. Importantly though, one must recognize the unique side effect profile of these therapies, which can trigger or exacerbate underlying autoimmune disease. Whether this autoimmune activation is associated with a clinical response to therapy has been debated, and while not definitive, there is evidence in the literature of a possible association...
October 2016: Journal of Investigative Medicine High Impact Case Reports
https://www.readbyqxmd.com/read/27822695/the-treatment-of-melanoma-brain-metastases
#8
REVIEW
Nour Kibbi, Harriet Kluger
Melanoma is the malignancy with the highest rate of dissemination to the central nervous system once it metastasizes. Until recently, the prognosis of patients with melanoma brain metastases (MBM) was poor. In recent years, however, the prognosis has improved due to high-resolution imaging that facilitates early detection of small asymptomatic brain metastases and early intervention with local modalities such as stereotactic radiosurgery. More recently, a number of systemic therapies have been approved by the Food and Drug Administration for metastatic melanoma, resulting in improved survival for many MBM patients...
December 2016: Current Oncology Reports
https://www.readbyqxmd.com/read/27800275/uveal-melanoma-current-trends-in-diagnosis-and-management
#9
REVIEW
Berçin Tarlan, Hayyam Kıratlı
Uveal melanoma, which is the most common primary intraocular malignancy in adults, arises from melanocytes within the iris, ciliary body and choroid. The diagnosis is based principally on clinical examination of the tumor with biomicroscopy and indirect ophthalmoscopy and confirmed by diagnostic techniques such as ultrasonography, fundus fluorescein angiography and optical coherence tomography. The clinical diagnosis of posterior uveal melanomas can be made when the classical appearance of a pigmented dome-shaped mass is detected on dilated fundus exam...
June 2016: Turkish Journal of Ophthalmology
https://www.readbyqxmd.com/read/27793401/near-infrared-intraoperative-molecular-imaging-can-locate-metastases-to-the-lung
#10
Jane Keating, Andrew Newton, Ollin Venegas, Sarah Nims, Ryan Zeh, Jarrod Predina, Charuhas Deshpande, John Kucharczuk, Shuming Nie, E James Delikatny, Sunil Singhal
BACKGROUND: Pulmonary metastasectomy is widely accepted for many tumor types because it may prolong survival and potentially cure some patients. However, intraoperative localization of pulmonary metastases can be technically challenging. We propose that intraoperative near-infrared (NIR) molecular imaging can be used as an adjunct during disease localization. METHODS: We inoculated 50 C57BL/6 mice with Lewis lung carcinoma (LLC) flank tumors. After flank tumor growth, mice were injected through the tail vein with indocyanine green (ICG) before operation, and intraoperative imaging was used to detect pulmonary metastases...
October 25, 2016: Annals of Thoracic Surgery
https://www.readbyqxmd.com/read/27785448/spotlight-on-talimogene-laherparepvec-for-the-treatment-of-melanoma-lesions-in-the-skin-and-lymph-nodes
#11
REVIEW
Marlana Orloff
On October 27, 2015, talimogene laherparepvec (T-VEC), a first in class intralesional oncolytic virotherapy, was granted the US Food and Drug Administration approval for the treatment of melanoma in the skin and lymph nodes. Its approval has added yet another therapeutic option to the growing list of effective therapies for melanoma. Though the Phase III OPTiM trial has demonstrated its efficacy as a single agent, the target patient population remains narrow. With numerous effective and tolerable treatments available for unresectable and metastatic melanoma, intralesional therapies such as T-VEC are still finding their niche...
2016: Oncolytic Virotherapy
https://www.readbyqxmd.com/read/27777773/antitumor-activity-of-nivolumab-on-hemodialysis-after-renal-allograft-rejection
#12
Michael Ong, Andrea Marie Ibrahim, Samuel Bourassa-Blanchette, Christina Canil, Todd Fairhead, Greg Knoll
BACKGROUND: Nivolumab (Opdivo™) is a novel IgG4 subclass programmed death-1 (PD-1) inhibiting antibody that has demonstrated breakthrough-designation anti-tumor activity. To date, clinical trials of nivolumab and other checkpoint inhibitors have generally excluded patients with solid organ transplantation and patients with concurrent immunosuppression. However, organ transplant recipients are at high-risk of development of malignancy as a result of suppressed immune surveillance of cancer...
2016: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/27766547/drug-combinations-as-the-new-standard-for-melanoma-treatment
#13
Marta Polkowska, Edyta Czepielewska, Małgorzata Kozłowska-Wojciechowska
Advanced melanoma is related to a very grim prognosis and fast progression. Until recently, there has been no indicated treatment that would affect the disease's outcome. However, the progress in immunotherapy and molecular therapy has significantly changed the unfavourable prognosis of melanoma progression and its short survival rate. Both approaches have improved patients' outcomes and provided renewed hope for successful treatment. Moreover, in order to further enhance patients' outcomes and to avoid mechanisms of tumour resistance, investigators attempted a combined approach...
December 2016: Current Treatment Options in Oncology
https://www.readbyqxmd.com/read/27757300/mrna-transfected-dendritic-cell-vaccine-in-combination-with-metronomic-cyclophosphamide-as-treatment-for-patients-with-advanced-malignant-melanoma
#14
Troels Holz Borch, Lotte Engell-Noerregaard, Trine Zeeberg Iversen, Eva Ellebaek, Özcan Met, Morten Hansen, Mads Hald Andersen, Per Thor Straten, Inge Marie Svane
INTRODUCTION: Vaccination with dendritic cells (DCs) has generally not fulfilled its promise in cancer immunotherapy due to ineffective translation of immune responses into clinical responses. A proposed reason for this is intrinsic immune regulatory mechanisms, such as regulatory T cells (Tregs). A metronomic regimen of cyclophosphamide (mCy) has been shown to selectively deplete Tregs. To test this in a clinical setting, we conducted a phase I trial to evaluate the feasibility and safety of vaccination with DCs transfected with mRNA in combination with mCy in patients with metastatic malignant melanoma (MM)...
2016: Oncoimmunology
https://www.readbyqxmd.com/read/27739125/toxic-epidermal-necrolysis-induced-by-vemurafenib-after-nivolumab-failure
#15
M Arenbergerova, I Mrazova, J Horazdovsky, E Sticova, A Fialova, P Arenberger
Vemurafenib is a selective inhibitor of the BRAF-kinase approved for the treatment of metastatic melanoma harboring BRAF mutation. Skin toxicity, including maculopapular exanthema, photosensitivity and keratoacanthoma, are the most common treatment-related adverse events of vemurafenib, affecting more than 90% of patients (1,2). It rarely presents with intense severity, with less than 1% of grade-4 toxicities reported in clinical trials (3,4). This article is protected by copyright. All rights reserved.
October 14, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/27701080/cobimetinib-a-novel-mek-inhibitor-for-metastatic-melanoma
#16
Jessie Signorelli, Arpita Shah Gandhi
OBJECTIVE: To review and summarize data on cobimetinib, which was approved by the US Food and Drug Administration (FDA) in November 2015 for use in combination with vemurafenib for unresectable or metastatic melanoma with a BRAFV600E or V600K mutation. DATA SOURCES: A literature search using PubMed was conducted using the terms cobimetinib, MEK inhibitor, and melanoma from January 2000 to June 2016. STUDY SELECTION AND DATA EXTRACTION: The literature search was confined to human studies published in English...
October 3, 2016: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/27699043/comparative-safety-of-braf-and-mek-inhibitors-vemurafenib-dabrafenib-and-trametinib-in-first-line-therapy-for-braf-mutated-metastatic-melanoma
#17
Ana Cebollero, Teresa Puértolas, Isabel Pajares, Lourdes Calera, Antonio Antón
A retrospective observational study was conducted on patients diagnosed with serine/threonine-protein kinase B-Raf (BRAF)-mutated metastatic melanoma, who underwent first-line therapy with BRAF and mitogen-activated protein kinase kinase (MEK) inhibitors (vemurafenib, dabrafenib or a combination of dabrafenib and trametinib) at the Miguel Servet University Hospital (Zaragoza, Spain) between November, 2011 and August, 2015. The aim of this study was to analyse the toxicity produced by BRAF and MEK inhibitors...
October 2016: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/27689027/targeted-cancer-therapy-using-engineered-salmonella-typhimurium
#18
REVIEW
Jin Hai Zheng, Jung-Joon Min
Obligate or facultative anaerobic bacteria such as Bifidobacterium, Clostridium, Salmonella, or Escherichia coli specifically colonize and proliferate inside tumor tissues and inhibit tumor growth. Among them, attenuated Salmonella typhimurium (S. typhimurium) has been widely studied in animal cancer models and Phase I clinical trials in human patients. S. typhimurium genes are easily manipulated; thus diverse attenuated strains of S. typhimurium have been designed and engineered as tumor-targeting therapeutics or drug delivery vehicles that show both an excellent safety profile and therapeutic efficacy in mouse models...
September 2016: Chonnam Medical Journal
https://www.readbyqxmd.com/read/27681753/a-prospective-clinical-trial-combining-radiation%C3%A2-therapy-with-systemic-immunotherapy-in%C3%A2-metastatic-melanoma
#19
Susan M Hiniker, Sunil A Reddy, Holden T Maecker, Priyanka B Subrahmanyam, Yael Rosenberg-Hasson, Susan M Swetter, Saurabh Saha, Lei Shura, Susan J Knox
PURPOSE: Local radiation therapy (RT) combined with systemic anti-cytotoxic T-lymphocyte-associated protein-4 immunotherapy may enhance induction of systemic antimelanoma immune responses. The primary objective of the present trial was to assess the safety and efficacy of combining ipilimumab with RT in patients with stage IV melanoma. The secondary objectives included laboratory assessment of induction of antimelanoma immune responses. METHODS AND MATERIALS: In our prospective clinical trial, 22 patients with stage IV melanoma were treated with palliative RT and ipilimumab for 4 cycles...
November 1, 2016: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/27680009/-cutaneous-squamous-cell-carcinoma
#20
REVIEW
U Leiter, R Gutzmer, M Alter, C Ulrich, A S Lonsdorf, M M Sachse, U Hillen
Squamous cell carcinoma (SCC) of the skin accounts for 20 % of non-melanoma skin cancer and is one of the most frequent types of cancer in Caucasian populations. Diagnosis is based on the clinical features and should be histopathologically confirmed to adequately address the prognosis and treatment. Complete surgical excision with histopathological control of excision margins is the gold standard in the treatment of primary SCC. Sentinel lymph node biopsies (SLNB) can be considered in SCC with a tumor thickness of >6 mm but there is currently no evidence concerning prognostic and therapeutic effects...
November 2016: Der Hautarzt; Zeitschrift Für Dermatologie, Venerologie, und Verwandte Gebiete
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