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Infusional therapy

David C Hess, Lawrence R Wechsler, Wayne M Clark, Sean I Savitz, Gary A Ford, David Chiu, Dileep R Yavagal, Ken Uchino, David S Liebeskind, Alexander P Auchus, Souvik Sen, Cathy A Sila, Jeffrey D Vest, Robert W Mays
BACKGROUND: Multipotent adult progenitor cells are a bone marrow-derived, allogeneic, cell therapy product that modulates the immune system, and represents a promising therapy for acute stroke. We aimed to identify the highest, well-tolerated, and safest single dose of multipotent adult progenitor cells, and if they were efficacious as a treatment for stroke recovery. METHODS: We did a phase 2, randomised, double-blind, placebo-controlled, dose-escalation trial of intravenous multipotent adult progenitor cells in 33 centres in the UK and the USA...
May 2017: Lancet Neurology
Nina Shah, Li Li, Jessica McCarty, Indreshpal Kaur, Eric Yvon, Hila Shaim, Muharrem Muftuoglu, Enli Liu, Robert Z Orlowski, Laurence Cooper, Dean Lee, Simrit Parmar, Kai Cao, Catherine Sobieiski, Rima Saliba, Chitra Hosing, Sairah Ahmed, Yago Nieto, Qaiser Bashir, Krina Patel, Catherine Bollard, Muzaffar Qazilbash, Richard Champlin, Katy Rezvani, Elizabeth J Shpall
Multiple myeloma (MM) is a disease with known immune dysregulation. Natural killer (NK) cells have shown preclinical activity in MM. We conducted a first-in-human study of umbilical cord blood-derived (CB) NK cells for MM patients undergoing high dose chemotherapy and autologous haematopoietic stem cell transplantation (auto-HCT). Patients received lenalidomide (10 mg) on days -8 to -2, melphalan 200 mg/m(2) on day -7, CB-NK cells on day -5 and auto-HCT on day 0. Twelve patients were enrolled, three on each of four CB-NK cell dose levels: 5 × 10(6) , 1 × 10(7) , 5 × 10(7) and 1 × 10(8) CB-NK cells/kg...
May 2017: British Journal of Haematology
Olivier Detry, Morgan Vandermeulen, Marie-Hélène Delbouille, Joan Somja, Noella Bletard, Alexandra Briquet, Chantal Lechanteur, Olivier Giet, Etienne Baudoux, Muriel Hannon, Frederic Baron, Yves Beguin
BACKGROUND & AIM: Mesenchymal stromal cell (MSC) infusion could be a mean to establish tolerance in solid organ recipients. The aim of this prospective, controlled, phase-1 study was to evaluate the feasibility, safety and tolerability of a single infusion of MSCs in liver transplant recipients. METHODS: Ten liver transplant recipients under standard immunosuppression received 1.5-3x10(6)/kg third-party unrelated MSCs on post-operative day 3±2, and were prospectively compared to a control group of 10 liver transplant recipients...
March 8, 2017: Journal of Hepatology
Belinda A Di Bartolo, Nisha Schwarz, Jordan Andrews, Stephen J Nicholls
High-density lipoproteins (HDL) have received considerable interest as a target for the development of novel anti-atherosclerotic agents beyond conventional approaches to lipid lowering. While a number of approaches have focused on modifying remodeling and expression pathways implicated in the regulation of HDL levels, an additional approach involves simply infusions of delipidated HDL. Several groups have advanced HDL infusions to clinical development with intriguing signs suggesting potentially favorable impacts at the level of the artery wall...
February 1, 2017: Archives of Medical Science: AMS
V A Kudinov, O M Ipatova, I G Fyodorov, G G Totolyan, N N Merzlikina, O B Kovalyov, T I Torkhovskaya, V F Uchaikin, I E Starovoitova, D V Milyutin, S M Nikonova
This paper presents the results of clinical studies on the efficacy and safety of the drug Phospholipovit in different groups of patients, in particular with hepatic encephalopathy and with a high risk of its development (chronic alcohol intoxication). Efficacy of treatmernt was evaluated by the LNT test (link numbers test), and standard liver plasma markers (ALT, AST, GGT, AP). The LNT test in patients with encephalopathy showed better improvement after 5 days course of Phos-pholipovit than after standard therapy...
November 2016: Biomedit︠s︡inskai︠a︡ Khimii︠a︡
Christian L Johnson, Yorick Soeder, Marc H Dahlke
PURPOSE OF REVIEW: The current review presents an update on the existing preclinical and human experience of mesenchymal stromal cell (MSC) therapies for post-transplant immunomodulation. RECENT FINDINGS: Although results from early clinical studies have demonstrated that the application of autologous and allogeneic MSC to be both safe and feasible in a solid organ transplantation setting, for example in liver, the efficacy of MSC immunotherapy demonstrated in preclinical models has yet to be replicated in human clinical trials...
December 2016: Current Opinion in Organ Transplantation
Rebecca B Goody, Helen MacKay, Bethany Pitcher, Amit Oza, Lillian L Siu, John Kim, Rebecca K S Wong, Eric Chen, Carol Swallow, Jennifer Knox, Zahra Kassam, Bernard Cummings, Ron Feld, David Hedley, Geoffrey Liu, Monika K Krzyzanowska, Robert Dinniwell, Anthony M Brade, Laura A Dawson, Melania Pintilie, Jolie Ringash
PURPOSE: Locoregional recurrence is common after surgery for gastric cancer. Adjuvant therapy improves outcomes but with toxicity. This phase 1/2 study investigated infusional 5-fluorouracil (5-FU) in combination with biweekly cisplatin delivered concurrently with image guided high-precision radiation therapy. METHODS AND MATERIALS: Eligible patients had completely resected stage IB to IV (Union for International Cancer Control TNM 6th edition) nonmetastatic gastric adenocarcinoma...
December 1, 2016: International Journal of Radiation Oncology, Biology, Physics
Sharlene Gill, Yoo-Joung Ko, Christine Cripps, Annie Beaudoin, Sukhbinder Dhesy-Thind, Muhammad Zulfiqar, Pawel Zalewski, Thuan Do, Pablo Cano, Wendy Yin Han Lam, Scot Dowden, Helene Grassin, John Stewart, Malcolm Moore
PURPOSE: The standard of care for second-line therapy in patients with advanced pancreatic cancer after gemcitabine-based therapy is not clearly defined. The CONKO-003 phase III study reported a survival benefit with second-line fluorouracil (FU) and oxaliplatin using the oxaliplatin, folinic acid, and FU (OFF) regimen.(1) PANCREOX was a phase III multicenter trial to evaluate the benefit of FU and oxaliplatin administered as modified FOLFOX6 (mFOLFOX6; infusional fluorouracil, leucovorin, and oxaliplatin) versus infusional FU/leucovorin (LV) in this setting...
September 12, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Tobias Engel Ayer Botrel, Luciana Gontijo de Oliveira Clark, Luciano Paladini, Otávio Augusto C Clark
BACKGROUND: Colorectal cancer (CRC) is the fourth most frequently diagnosed cancer and the second leading cause of neoplasm-related death in the United States. Several studies analyzed the efficacy of bevacizumab combined with different chemotherapy regimens consisting on drugs such as 5-FU, capecitabine, irinotecan and oxaliplatin. This systematic review aims to evaluate the effectiveness and safety of chemotherapy plus bevacizumab versus chemotherapy alone in patients with previously untreated advanced or metastatic colorectal cancer (mCRC)...
2016: BMC Cancer
Mamoru Uemura, Ho Min Kim, Tsuyoshi Hata, Kazuya Sakata, Masaki Okuyama, Hiroyoshi Takemoto, Hitoshi Fujii, Takayuki Fukuzaki, Tetsushi Morita, Taishi Hata, Ichiro Takemasa, Taroh Satoh, Tsunekazu Mizushima, Yuichiro Doki, Maski Mori
Colorectal cancer (CRC) is one of the most commonly occurring cancers worldwide. A burgeoning number of studies have demonstrated that the addition of cetuximab to another standard first-line regimen markedly improves the outcome of CRC treatment. However, at present, the efficacy and safety of cetuximab-based combination chemotherapy has not been well described in Japan. The aim of the present study was to evaluate the efficacy and safety of first-line chemotherapies that included cetuximab for patients with advanced or metastatic Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type CRC in Japan...
August 2016: Molecular and Clinical Oncology
Anna De Rosa, Alessandro Tessitore, Leonilda Bilo, Silvio Peluso, Giuseppe De Michele
Parkinson's Disease (PD) represents one of the most common neurodegenerative disorders in the elderly. PD is caused by a loss of dopaminergic cells in the substantia nigra pars compacta. The motor cardinal signs include a resting tremor, bradykinesia, rigidity and postural reflex impairment. Although levodopa represents the gold standard also in the advanced stage of the disease, over the years most patients develop disabling motor fluctuations, dyskinesias, and non-motor complications, which are difficult to manage...
November 2016: Geriatric Nursing
C Kent, E M Bessell, J H Scholefield, S Chappell, L Marsh, J Mills, I Sayers
PURPOSE: The aim of this study is to determine overall survival, disease-specific survival and stoma-free survival after treatment of squamous cell carcinoma of the anus with chemoradiotherapy followed by brachytherapy or electron boost in a recent cohort of patients. METHODS: Fifty-two patients (median age 62 years) were treated with radical chemoradiotherapy (mitomycin C, infusional 5-fluorouracil concurrently with conformal radical radiotherapy 45 Gy in 25 fractions over 5 weeks) followed by a radiotherapy boost between 1 December 2000 and 30 April 2011...
March 2017: Journal of Gastrointestinal Cancer
Mohamed E Salem, Marion Hartley, Keith Unger, John L Marshall
Rectal cancer treatment presents a challenge, and its optimal management requires a multidisciplinary approach involving surgical, medical, and radiation oncologists. Advances in surgical techniques, radiotherapy, and medical imaging technology have transformed the therapeutic landscape and have led to substantial improvements in both local disease control and patient survival. The currently established standard of care for patients with locally advanced rectal cancer involves preoperative (neoadjuvant) concurrent radiotherapy and infusional fluorouracil-based or oral capecitabine-based chemotherapy, also known as chemoradiotherapy (CRT), followed by surgery...
June 2016: Oncology (Williston Park, NY)
Leyla Kilic, Cetin Ordu, Ibrahim Yildiz, Fatma Sen, Serkan Keskin, Rumeysa Ciftci, Kezban Nur Pilanci
The discrepancy between the surgical technique and the type of adjuvant chemotherapy used in clinical trials and patient outcomes in terms of overall survival rates has led to the generation of different adjuvant treatment protocols in distinct parts of the world. The adjuvant treatment recommendation is generally chemoradiotherapy in the United States, perioperative chemotherapy in the United Kingdom and parts of Europe, and chemotherapy in Asia. These options mainly rely on the United States Intergroup-0116, United Kingdom British Medical Research Council Adjuvant Gastric Infusional Chemotherapy, and the Asian Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer and Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer trials...
May 15, 2016: World Journal of Gastrointestinal Oncology
Toru Yoshikawa, Kazunori Aoki, Yuto Mitsuhashi, Satoko Tomiura, Akiko Suto, Takuya Miura, Shojirokazunori Ikenaga, Itaru Shibasaki, Masaaki Endo
A 61-year-old man was admitted to our hospital because of a complaint of blood in stool. He was diagnosed with advanced colon and gastric cancers. Computed tomography (CT) revealed a sigmoid tumor with invasion to the bladder, a metastatic tumor in the lateral segmental branch of the left hepatic lobe, and ascites. He was diagnosed with initially unresectable double cancer. Ileostomy was performed immediately, and he was treated with modified (m) FOLFOX6 regimen (oxaliplatin in combination with infusional 5-fluorouracil/Leucovorin)...
March 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
Heather L Lewis, Mark Bloomston
Hepatic artery infusion (HAI) therapy is a well-studied and viable regional therapy for patients with hepatic metastases. Implantable pump devices may be safely placed intraarterially with minimal morbidity and HAI treatments can be used as an adjunct to systemic therapy. Future trials may address sequencing of regional and systemic therapies. However, HAI is not without complications and requires close monitoring and attention to detail but can offer reasonable control of liver tumor burden when managed jointly between medical and surgical oncologists...
April 2016: Surgical Clinics of North America
M Bupathi, D H Ahn, C Wu, K K Ciombor, J A Stephens, J Reardon, D A Goldstein, T Bekaii-Saab
Pancreatic adenocarcinoma is the fourth leading cause of cancer death. Recently, MM-398 (nanoliposomal irinotecan) was shown to be associated with significant improvement in outcome measures with acceptable toxicities when combined with 5-fluorouracil (5-FU)/leucovorin (LV) compared to 5-FU/LV alone in patients failing one line of gemcitabine-based therapy. There is a paucity of data evaluating the role of irinotecan in combination with 5FU in advanced pancreas cancer (APC). We performed a retrospective analysis of all patients who received mFOLFIRI (minus bolus 5FU and LV)...
April 2016: Medical Oncology
Patrick M Boland, Joshua E Meyer, Adam C Berger, Steven J Cohen, Tzahi Neuman, Harry S Cooper, Anthony J Olszanski, Monica Davey, Jonathan D Cheng, Abraham Lebenthal, Barbara A Burtness, Walter J Scott, Igor A Astsaturov
OBJECTIVES: Preoperative chemotherapy and radiation for localized esophageal cancer produces cure rates near 30% when combined with surgical resection. Vandetanib, a small molecule receptor tyrosine kinase inhibitor of VEGFR-2, VEGFR-3, RET, and EGFR, demonstrated synergy with radiation and chemotherapy in preclinical models. We conducted a phase I study to assess the safety and tolerability of vandetanib when combined with preoperative chemoradiation in patients with localized esophageal carcinoma who were surgical candidates...
March 16, 2016: American Journal of Clinical Oncology
Amparo Sanchez-Gastaldo, Reyes Gonzalez-Exposito, Rocío Garcia-Carbonero
Ramucirumab (IMC-1121B, LY3009806) is a fully human G1 monoclonal antibody that specifically targets vascular endotelial growth factor receptor 2 (VEGFR-2) with a substantially greater binding affinity than that of its natural ligands. Early clinical trials in patients with advanced solid tumors demonstrated that biologically relevant blood target concentrations are achievable with tolerable doses, and also showed some preliminary evidence of clinical activity. Several pivotal phase III trials have now been concluded and have led regulatory agencies to grant marketing authorization to ramucirumab for use as second line therapy in patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma (as single agent or in combination with paclitaxel), in patients with advanced colorectal carcinoma (CRC) (in combination with infusional fluorouracil and irinotecan (FOLFIRI regimen)) and in patients with advanced non-small cell lung cancer (NSCLC) (in combination with docetaxel)...
August 2016: Targeted Oncology
Richard Kim, Gopi Kesaria Prithviraj, Ravi Shridhar, Sarah E Hoffe, Kun Jiang, Xiuhua Zhao, Dung-Tsa Chen, Khaldoun Almhanna, Jonathan Strosberg, Tiffany Campos, David Shibata
PURPOSE: The standard of care in locally advanced rectal cancer is preoperative treatment with fluoropyrimidine-based chemoradiotherapy. Sorafenib works synergistically with radiation and inhibits Ras/Raf, PDFGR, and VEGFR. This phase I study evaluated the safety and efficacy of sorafenib with infusional 5-fluorouracil (5-FU) and radiation in patients with locally advanced rectal cancer. METHODS AND MATERIALS: Patients with confirmed stage II or III rectal cancer were recruited in 4 cohorts of 3 patients per dose level, with an expansion cohort at the maximum tolerated dose...
February 2016: Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology
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