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Dose escalation

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https://www.readbyqxmd.com/read/28102485/-18-f-fet-pet-prior-to-recurrent-high-grade-glioma-re-irradiation-additional-prognostic-value-of-dynamic-time-to-peak-analysis-and-early-static-summation-images
#1
Daniel F Fleischmann, Marcus Unterrainer, Peter Bartenstein, Claus Belka, Nathalie L Albert, Maximilian Niyazi
Most high-grade gliomas (HGG) recur after initial multimodal therapy and re-irradiation (Re-RT) has been shown to be a valuable re-treatment option in selected patients. We evaluated the prognostic value of dynamic time-to-peak analysis and early static summation images in O-(2-(18)F-fluoroethyl)-l-tyrosine ((18)F-FET) PET for patients treated with Re-RT ± concomitant bevacizumab. We retrospectively analyzed 72 patients suffering from recurrent HGG with (18)F-FET PET prior to Re-RT. PET analysis revealed the maximal tumor-to-background-ratio (TBRmax), the biological tumor volume, the number of PET-foci and pattern of time-activity-curves (TACs; increasing vs...
January 19, 2017: Journal of Neuro-oncology
https://www.readbyqxmd.com/read/28100688/the-use-of-oxytocin-to-improve-feeding-and-social-skills-in-infants-with-prader-willi-syndrome
#2
Maïthé Tauber, Kader Boulanouar, Gwenaelle Diene, Sophie Çabal-Berthoumieu, Virginie Ehlinger, Pascale Fichaux-Bourin, Catherine Molinas, Sandy Faye, Marion Valette, Jeanne Pourrinet, Catie Cessans, Sylvie Viaux-Sauvelon, Céline Bascoul, Antoine Guedeney, Patric Delhanty, Vincent Geenen, Henri Martens, Françoise Muscatelli, David Cohen, Angèle Consoli, Pierre Payoux, Catherine Arnaud, Jean-Pierre Salles
BACKGROUND AND OBJECTIVES: Patients with Prader-Willi syndrome (PWS) display poor feeding and social skills as infants and fewer hypothalamic oxytocin (OXT)-producing neurons were documented in adults. Animal data demonstrated that early treatment with OXT restores sucking after birth. Our aim is to reproduce these data in infants with PWS. METHODS: We conducted a phase 2 escalating dose study of a short course (7 days) of intranasal OXT administration. We enrolled 18 infants with PWS under 6 months old (6 infants in each step) who received 4 IU of OXT either every other day, daily, or twice daily...
January 18, 2017: Pediatrics
https://www.readbyqxmd.com/read/28100282/optimal-regimens-of-sulfamethoxazole-trimethoprim-for-chemoprophylaxis-of-pneumocystis-pneumonia-in-patients-with-systemic-rheumatic-diseases-results-from-a-non-blinded-randomized-controlled-trial
#3
Masako Utsunomiya, Hiroaki Dobashi, Toshio Odani, Kazuyoshi Saito, Naoto Yokogawa, Kenji Nagasaka, Kenchi Takenaka, Makoto Soejima, Takahiko Sugihara, Hiroyuki Hagiyama, Shinya Hirata, Kazuo Matsui, Yoshinori Nonomura, Masahiro Kondo, Fumihito Suzuki, Makoto Tomita, Mari Kihara, Waka Yokoyama, Fumio Hirano, Hayato Yamazaki, Ryoko Sakai, Toshihiro Nanki, Ryuji Koike, Hitoshi Kohsaka, Nobuyuki Miyasaka, Masayoshi Harigai
BACKGROUND: Sulfamethoxazole-trimethoprim (SMX/TMP) is a standard drug for the prophylaxis of Pneumocystis pneumonia (PJP) in immunosuppressed patients with systemic rheumatic diseases, but is sometimes discontinued due to adverse events (AEs). The objective of this non-blinded, randomized, 52-week non-inferiority trial was to quest an effective chemoprophylaxis regimen for PJP with a low drug discontinuation rate. Results at week 24 were reported. METHODS: Adult patients with systemic rheumatic diseases who started prednisolone ≥0...
January 18, 2017: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/28097534/successful-treatment-with-low-dose-nivolumab-in-refractory-hodgkin-lymphoma-after-allogeneic-stem-cell-transplantation
#4
Makoto Onizuka, Minoru Kojima, Keiko Matsui, Shinichiro Machida, Masako Toyosaki, Yasuyuki Aoyama, Hidetsugu Kawai, Jun Amaki, Ryujiro Hara, Akifumi Ichiki, Yoshiaki Ogawa, Hiroshi Kawada, Naoya Nakamura, Kiyoshi Ando
Previous studies have reported that an antibody that blocks programmed cell death 1 (PD-1) has therapeutic activity in patients with refractory/relapsed Hodgkin lymphoma (HL). However, the safety and efficacy of these agents in the post-allogeneic stem cell transplantation (allo-SCT) setting are not well known. Here, we describe a patient who was diagnosed as classical HL and treated with five regimens of chemotherapies with autologous SCT. Complete remission (CR) was not achieved following this initial treatment, so we performed allo-SCT from an HLA-matched sibling donor...
January 17, 2017: International Journal of Hematology
https://www.readbyqxmd.com/read/28097385/two-phase-1-dose-escalation-studies-exploring-multiple-regimens-of-litronesib-ly2523355-an-eg5-inhibitor-in-patients-with-advanced-cancer
#5
Jeffrey R Infante, Amita Patnaik, Claire F Verschraegen, Anthony J Olszanski, Montaser Shaheen, Howard A Burris, Anthony W Tolcher, Kyriakos P Papadopoulos, Muralidhar Beeram, Scott M Hynes, Jennifer Leohr, Aimee Bence Lin, Lily Q Li, Anna McGlothlin, Daphne L Farrington, Eric H Westin, Roger B Cohen
PURPOSE: This first-in-human report examined the recommended Phase 2 dose and schedule of litronesib, a selective allosteric kinesin Eg5 inhibitor. METHODS: Two concurrent dose-escalation studies investigated litronesib across the dose range of 0.125-16 mg/m(2)/day, evaluating the following schedules of administration on a 21-day cycle: Days 1, 2, 3; Days 1, 5, 9; Days 1, 8; Days 1, 5; or Days 1, 4, with or without pegfilgrastim. Best overall response was defined per Response Evaluation Criteria in Solid Tumors (RECIST Version 1...
January 17, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28096296/a-critical-asthma-standardized-clinical-and-management-plan-reduces-duration-of-critical-asthma-therapy
#6
Jackson Wong, Michael S D Agus, Dionne A Graham, Elliot Melendez
BACKGROUND AND OBJECTIVE: Reduction of critical asthma management time can reduce intensive care utilization. The goal of this study was to determine whether a Critical Asthma Standardized Clinical Assessment and Management Plan (SCAMP) can decrease length of critical asthma management time. METHODS: This retrospective study compared critical asthma management times in children managed before and after implementation of a Critical Asthma SCAMP. The SCAMP used an asthma severity score management scheme to guide stepwise escalation and weaning of therapies...
January 17, 2017: Hospital Pediatrics
https://www.readbyqxmd.com/read/28095882/the-use-of-dose-escalated-radiation-for-locally-advanced-non-small-cell-lung-cancer-in-the-u-s-2004-2013
#7
John P Christodouleas, Matthew D Hall, Marjorie A van der Pas, Wensheng Guo, Timothy E Schultheiss, Peter Gabriel
PURPOSE/OBJECTIVES: The clinical effects of radiation dose-intensification in locally advanced non-small cell lung (NSCLCa) and other cancers are challenging to predict and are ideally studied in randomized trials. The purpose of this study was to assess the use of dose-escalated radiation for locally advanced NSCLCa in the U.S., 2004-2013, a period in which there were no published level 1 studies on dose-escalation. MATERIALS/METHODS: We performed analyses on two cancer registry databases with complementary strengths and weaknesses: the National Oncology Data Alliance (NODA) 2004-2013 and the National Cancer Database (NCDB) 2004-2012...
January 17, 2017: Radiation Oncology
https://www.readbyqxmd.com/read/28095258/the-safety-of-treatment-options-available-for-gout
#8
Naomi Schlesinger
Gout is the most common inflammatory arthritis in humans. Gout treatment includes rapid initiation of anti-inflammatory medications for acute attacks and chronically treating with urate lowering drugs as well as chronic anti-inflammatory prophylaxis. Areas covered: This review aims to provide an overview and discussion of the safety concerns of current treatment options available for gout. Expert opinion: Gout is a curable disease with appropriate treatment. The advent of new therapies provides encouraging opportunities to improve gout management...
January 17, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28095146/phase-i-first-in-human-study-of-venetoclax-in-patients-with-relapsed-or-refractory-non-hodgkin-lymphoma
#9
Matthew S Davids, Andrew W Roberts, John F Seymour, John M Pagel, Brad S Kahl, William G Wierda, Soham Puvvada, Thomas J Kipps, Mary Ann Anderson, Ahmed Hamed Salem, Martin Dunbar, Ming Zhu, Franklin Peale, Jeremy A Ross, Lori Gressick, Monali Desai, Su Young Kim, Maria Verdugo, Rod A Humerickhouse, Gary B Gordon, John F Gerecitano
Purpose B-cell leukemia/lymphoma-2 (BCL-2) overexpression is common in many non-Hodgkin lymphoma (NHL) subtypes. A phase I trial in patients with NHL was conducted to determine safety, pharmacokinetics, and efficacy of venetoclax, a selective, potent, orally bioavailable BCL-2 inhibitor. Patients and Methods A total of 106 patients with relapsed or refractory NHL received venetoclax once daily until progressive disease or unacceptable toxicity at target doses from 200 to 1,200 mg in dose-escalation and safety expansion cohorts...
January 17, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28095003/cocaine-addiction-as-a-homeostatic-reinforcement-learning-disorder
#10
Mehdi Keramati, Audrey Durand, Paul Girardeau, Boris Gutkin, Serge H Ahmed
Drug addiction implicates both reward learning and homeostatic regulation mechanisms of the brain. This has stimulated 2 partially successful theoretical perspectives on addiction. Many important aspects of addiction, however, remain to be explained within a single, unified framework that integrates the 2 mechanisms. Building upon a recently developed homeostatic reinforcement learning theory, the authors focus on a key transition stage of addiction that is well modeled in animals, escalation of drug use, and propose a computational theory of cocaine addiction where cocaine reinforces behavior due to its rapid homeostatic corrective effect, whereas its chronic use induces slow and long-lasting changes in homeostatic setpoint...
January 16, 2017: Psychological Review
https://www.readbyqxmd.com/read/28092666/loss-of-%C3%AE-opioid-receptor-signaling-in-nociceptors-but-not-microglia-abrogates-morphine-tolerance-without-disrupting-analgesia
#11
Gregory Corder, Vivianne L Tawfik, Dong Wang, Elizabeth I Sypek, Sarah A Low, Jasmine R Dickinson, Chaudy Sotoudeh, J David Clark, Ben A Barres, Christopher J Bohlen, Grégory Scherrer
Opioid pain medications have detrimental side effects including analgesic tolerance and opioid-induced hyperalgesia (OIH). Tolerance and OIH counteract opioid analgesia and drive dose escalation. The cell types and receptors on which opioids act to initiate these maladaptive processes remain disputed, which has prevented the development of therapies to maximize and sustain opioid analgesic efficacy. We found that μ opioid receptors (MORs) expressed by primary afferent nociceptors initiate tolerance and OIH development...
January 16, 2017: Nature Medicine
https://www.readbyqxmd.com/read/28092649/new-onset-depression-following-stable-slow-and-rapid-rate-of-prescription-opioid-dose-escalation
#12
Joanne Salas, Jeffrey F Scherrer, Frank David Schneider, Mark D Sullivan, Kathleen K Bucholz, Thomas Burroughs, Laurel A Copeland, Brian K Ahmedani, Patrick J Lustman
Recent studies suggest that longer durations of opioid use, independent of maximum morphine equivalent dose (MED) achieved, is associated with increased risk of new-onset depression (NOD). Conversely, other studies, not accounting for duration, found that higher MED increased probability of depressive symptoms. To determine whether rate of MED increase is associated with NOD, a retrospective cohort analysis of Veterans Health Administration data (2000-2012) was conducted. Eligible patients were new, chronic (>90 days) opioid users, aged 18 to 80, and without depression diagnoses for 2 years before start of follow-up (n = 7051)...
February 2017: Pain
https://www.readbyqxmd.com/read/28089762/long-terms-results-of-a-trial-of-concurrent-chemotherapy-and-escalating-doses-of-radiation-for-unresectable-non-small-cell-lung-cancer-ncctg-n0028-alliance
#13
Steven E Schild, Shauna L Hillman, Angelina D Tan, Helen J Ross, William L McGinnis, Yolanda A Garces, David L Graham, Alex A Adjei, James R Jett
INTRODUCTION OR HYPOTHESIS: This phase I/II trial was originally designed to determine the maximally tolerated dose(MTD) of thoracic radiotherapy(TRT) as part of a combined modality approach. This report includes the long-term outcome of patients treated on this study. The phase II portion was never completed as RTOG-0617 opened before it was concluded. METHODS: The MTD was defined as 74Gy in 37 fractions in this study. Twenty-five patients with unresectable non-small cell lung cancer(NSCLC) were treated with 2Gy daily fractions and concurrent weekly carboplatin and paclitaxel...
January 12, 2017: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/28089635/venetoclax-plus-rituximab-in-relapsed-or-refractory-chronic-lymphocytic-leukaemia-a-phase-1b-study
#14
John F Seymour, Shuo Ma, Danielle M Brander, Michael Y Choi, Jacqueline Barrientos, Matthew S Davids, Mary Ann Anderson, Anne W Beaven, Steven T Rosen, Constantine S Tam, Betty Prine, Suresh K Agarwal, Wijith Munasinghe, Ming Zhu, L Leanne Lash, Monali Desai, Elisa Cerri, Maria Verdugo, Su Young Kim, Rod A Humerickhouse, Gary B Gordon, Thomas J Kipps, Andrew W Roberts
BACKGROUND: Selective BCL2 inhibition with venetoclax has substantial activity in patients with relapsed or refractory chronic lymphocytic leukaemia. Combination therapy with rituximab enhanced activity in preclinical models. The aim of this study was to assess the safety, pharmacokinetics, and activity of venetoclax in combination with rituximab. METHODS: Adult patients with relapsed or refractory chronic lymphocytic leukaemia (according to the 2008 Modified International Workshop on CLL guidelines) or small lymphocytic lymphoma were eligible for this phase 1b, dose-escalation trial...
January 12, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28089528/hydrogel-spacer-distribution-within-the-perirectal-space-in-patients-undergoing-radiotherapy-for-prostate-cancer-impact-of-spacer-symmetry-on-rectal-dose-reduction-and-the-clinical-consequences-of-hydrogel-infiltration-into-the-rectal-wall
#15
Benjamin W Fischer-Valuck, Anupama Chundury, Hiram Gay, Walter Bosch, Jeff Michalski
PURPOSE: Hydrogel prostate-rectum spacers, biomaterials placed between the prostate and rectum, continue to gain interest as a method to reduce or limit rectal dose during dose escalated prostate cancer radiation therapy. Because the spacer is initially injected into the perirectal space as a liquid, the final distribution can vary. The purpose of this study was to evaluate hydrogel spacer (SpaceOAR system) implantation and distribution from a recent prospective randomized control trial and correlate spacer symmetry with rectal dose reduction as well as rectal wall infiltration (RWI) to acute and late toxicity...
October 17, 2016: Practical Radiation Oncology
https://www.readbyqxmd.com/read/28088967/-a-phase-%C3%A2-dose-escalating-trial-of-pegylated-liposomal-doxorubicin-in-combination-with-cyclophosphamide-vincristine-and-prednisone-for-aggressive-non-hodgkin-lymphoma
#16
W N Shen, D M Ji, K Xue, Q L Zhang, F F Lyu, X N Hong, J N Cao, Y Guo
Objective: To explore the maximum tolerated dose of pegylated liposomal doxorubicin (PLD) in combination with cyclophosphamide, vincristine and prednisone as a modified CHOP regimen for aggressive non-Hodgkin lymphoma. Methods: Patients with newly diagnosed aggressive non-Hodgkin lymphoma were eligible for this trial. PLD was administered in cycle 1 and categorized into 4 dose level (30 mg/m(2), 35 mg/m(2), 40 mg/m(2), 45 mg/m(2) D1) according to a 3 + 3 approach for dose-escalation. Doxorubin was used in cycles 2-6...
December 14, 2016: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
https://www.readbyqxmd.com/read/28087456/phase-i-trial-of-total-marrow-and-lymphoid-irradiation-transplant-conditioning-in-patients-with-relapsed-refractory-acute-leukemia
#17
Anthony Stein, Joycelynne Palmer, Ni-Chun Tsai, Monzr M Al Malki, Ibrahim Aldoss, Haris Ali, Ahmed Aribi, Len Farol, Chatchada Karanes, Samer Khaled, An Liu, Margaret O'Donnell, Pablo Parker, Anna Pawlowska, Vinod Pullarkat, Eric Radany, Joseph Rosenthal, Firoozeh Sahebi, Amandeep Salhotra, James F Sanchez, Tim Schultheiss, Ricardo Spielberger, Sandra H Thomas, David Snyder, Ryotaro Nakamura, Guido Marcucci, Stephen J Forman, Jeffrey Wong
Current conditioning regimens provide insufficient disease control in relapsed/refractory acute leukemia (AL) patients undergoing hematopoietic stem cell transplantation (HSCT) with active disease. Intensification of chemotherapy and/or total body irradiation (TBI) is not feasible because of excessive toxicity. Total marrow and lymphoid irradiation (TMLI) allows for precise delivery and increased intensity treatment via sculpting radiation to sites with high disease burden or high risk for disease involvement, while sparing normal tissue...
January 10, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28086942/external-beam-radiotherapy-for-unresectable-hepatocellular-carcinoma-an-international-multicenter-phase-i-trial-sakk-77-07-and-sasl-26
#18
Evelyn Herrmann, Diana Naehrig, Manfred Sassowsky, Martin Bigler, Jeroen Buijsen, Ilja Ciernik, Daniel Zwahlen, Alessandra Franzetti Pellanda, Andreas Meister, Peter Brauchli, Simona Berardi, Erika Kuettel, Jean-François Dufour, Daniel M Aebersold
PURPOSE: To assess feasibility and safety of conventionally fractionated radiotherapy (cfRT) in patients with hepatocellular carcinoma (HCC). METHODS: Patients with histologically confirmed stage cT1-4, cN0-1 HCC and Child-Pugh Score (CPS) A or B disease were included in a phase I multicenter trial. Metastatic HCC were allowed if ≥90% of total tumor volume was located within the liver. Patients were enrolled onto five dose-escalation levels (54-70Gy in 2Gy fractions) based on a modified 3 + 3 design, with cohorts of five patients instead of three patients in dose levels 4 and 5...
January 13, 2017: Radiation Oncology
https://www.readbyqxmd.com/read/28079601/infliximab-optimization-based-on-therapeutic-drug-monitoring-in-pediatric-ibd
#19
Tatyana Hofmekler, Madeline Bertha, Courtney McCracken, Benadette Martineau, Elizabeth McKinnon, Bess T Schoen, Barbara O McElhanon, Gayathri Tenjarla, Subra Kugathasan, Cary Sauer
BACKGROUND: Infliximab (IFX) is an effective treatment for the management of moderate to severe inflammatory bowel disease (IBD). Low serum IFX levels are associated with the development of antibodies to IFX (ATI) which subsequently associated with clinical relapse and increased morbidity. The purpose of this study is to examine the relationship between dose and interval to IFX level. Secondary goal is to evaluate the relationship between IFX level and ATI in a pediatric IBD population...
June 21, 2016: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28078678/a-seamless-phase-i-ii-dose-finding-trial-assessing-ingenol-disoxate-leo-43204-for-field-treatment-of-actinic-keratosis-on-the-scalp
#20
J Weiss, M Ulrich, M Bukhalo, M L Østerdal, B Bang, C W Hanke
BACKGROUND: Actinic keratosis (AK) is a common sun-related skin condition, which can progress to squamous cell carcinoma and occur in cancerised fields. OBJECTIVES: This Phase I/II trial investigated the safety and efficacy of ingenol disoxate as topical field therapy for patients with AK on the balding scalp. METHODS: Part 1 was a Phase I, open-label, dose-escalation trial investigating up to 6 doses of ingenol disoxate to determine the maximum tolerated dose (MTD)...
January 12, 2017: British Journal of Dermatology
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