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phase-3 and carcinoma

Nabia S Ikram, Judy Yee, Stefanie Weinstein, Benjamin M Yeh, Carlos U Corvera, Alexander Monto, Thomas A Hope
PURPOSE: To establish if triple-phase arterial imaging improves the detection of arterial phase hyperintense lesions based on arterial phase capture, motion artifact degradation, and lesion enhancement when compared to single-phase imaging. MATERIALS AND METHODS: Patients at risk for hepatocellular carcinoma were imaged at 3.0T. Seventy-three consecutive patients with a standard single-phase MRI and eighty-five consecutive patients were imaged using extracellular contrast with triple arterial phase MRI using three sequential accelerated acquisitions of 8 s...
October 21, 2016: Abdominal Radiology
Hideomi Yamashita, Ryousuke Takenaka, Kae Okuma, Kuni Ootomo, Keiichi Nakagawa
BACKGROUND: A prospective study was performed on the use of chemoradiotherapy (CRT) for esophageal cancer (EC) with involved-field radiation therapy (IFRT), based on 18-fluorodeoxyglucose positron-emission tomography. Prognostic factors for overall survival (OS) were analyzed. METHODS: Eligible patients included 63 adults with newly diagnosed, untreated, inoperable stage I-IV EC with lymph node metastases. Patients received 80 mg/m(2) nedaplatin per day on day 1, 800 mg/m(2) 5-fluorouracil on days 1-4 intravenously repeated every 28 days for two to four cycles, and combined IFRT...
September 2016: Thoracic Cancer
Jing Zhang, Yuan Zong, Gang-Zhu Xu, Ke Xing
OBJECTIVES: To evaluate the efficacy and safety of erlotinib for the treatment of advanced hepatocellular carcinoma (HCC). METHODS: A systematic literature search was undertaken in June 2015. Phase II/III trials of erlotinib for the treatment of advanced HCC were included. A descriptive analysis was applied. The study was conducted in College of Medicine, Honghui Hospital, Xi'an Jiaotong University, Xi'an, China, between June 2015 and January 2016. RESULTS: Ten trials, comprising 9 phase II and one phase III trial, were included in the systematic review...
November 2016: Saudi Medical Journal
Wataru Obara, Takashi Karashima, Kazuyoshi Takeda, Renpei Kato, Yoichiro Kato, Mitsugu Kanehira, Ryo Takata, Keiji Inoue, Toyomasa Katagiri, Taro Shuin, Yusuke Nakamura, Tomoaki Fujioka
PURPOSE: Through genome-wide expression profile analysis, hypoxia-inducible protein 2 (HIG2) has previously been identified as an oncoprotein involved in development/progression of renal cell carcinoma (RCC). We subsequently identified a highly immunogenic HLA-A*0201/0206-restricted epitope peptide (HIG2-9-4) corresponding to a part of HIG2 and applied it as a therapeutic vaccine. We conducted a phase I clinical trial using the HIG2-9-4 peptide for patients with advanced RCC. MATERIALS AND METHODS: Nine patients having HLA-A*0201 or HLA-A*0206 with metastatic or unresectable RCC after failure of the cytokine and/or tyrosine kinase inhibitor therapies were enrolled in this study...
October 18, 2016: Cancer Immunology, Immunotherapy: CII
Andrew Zloza, Neal D Dharmadhikari, Erica J Huelsmann, Joseph R Broucek, Tasha Hughes, Frederick J Kohlhapp, Howard L Kaufman
Recombinant interleukin-2 (rIL-2) is associated with objective responses in 15-20 % of patients with metastatic melanoma and renal cell carcinoma. More recently, rIL-2 has also demonstrated improved clinical activity in patients with melanoma. Given the toxicity of high-dose rIL-2 and the availability of many new immunotherapy agents, it has been suggested that lower doses of rIL-2 may be preferred for combination clinical studies. In order to determine the impact of low doses of rIL-2 on anti-tumor immunity and therapeutic effectiveness, we challenged C57BL/6 mice with poorly immunogenic B16-F10 melanoma and treated them with varying doses of rIL-2 (range 10(3)-10(5) IU)...
October 18, 2016: Cancer Immunology, Immunotherapy: CII
G-Y Li, J-Z Liu, L Zhang, S-J Li, G-Z Liu, T-W Xiao, J-X Wang, L-X Wang, M Hou
Serine/threonine protein phosphatase 5 (PPP5C) participates in multiple signaling pathways including cell cycle control and cell growth. PPP5C is involved in the progression of human breast cancer and hepatocellular carcinoma. However, its function in acute myelogenous leukemia (AML) remains unknown. In this study, we constructed a lentivirus system to knock down the expression level of PPP5C in leukemic cell line U937. Cell proliferation and cell cycles were assessed by MTT assay and flow cytometry respectively...
September 30, 2016: Cellular and Molecular Biology
Satoshi Nagayama, Suguru Hasegawa, Koya Hida, Kenji Kawada, Etsuro Hatano, Kojiro Nakamura, Satoru Seo, Kojiro Taura, Kentaro Yasuchika, Takashi Matsuo, Masazumi Zaima, Akiyoshi Kanazawa, Hiroaki Terajima, Masaharu Tada, Yukihito Adachi, Ryuta Nishitai, Dai Manaka, Tsunehiro Yoshimura, Koji Doi, Takahiro Horimatsu, Akira Mitsuyoshi, Kenichi Yoshimura, Miyuki Niimi, Shigemi Matsumoto, Yoshiharu Sakai, Shinji Uemoto
BACKGROUND: Although liver resection combined with preoperative chemotherapy is expected to improve outcomes of patients with resectable colorectal liver metastasis (CRLM), there is as yet insufficient clinical evidence supporting the efficacy of preoperative systemic chemotherapy. The aim of this phase II study was to assess the feasibility and efficacy of preoperative FOLFOX systemic chemotherapy for patients with initially resectable CRLM. METHODS: A prospective multi-institutional phase II study was conducted to evaluate the feasibility and efficacy of preoperative chemotherapy for resectable CRLM (ClinicalTrials...
October 17, 2016: International Journal of Clinical Oncology
Sedar Karakurt
Expression of a drug and xenobiotic metabolizing enzymes, cytochrome P450s (CYPs), and antioxidant enzymes can be modulated by various factors. The flavonoid rutin was investigated for its anti-carcinogen and protective effects as well as modulatory action on CYPs and phase II enzymes in human hepatocellular carcinoma cells. Rutin inhibited proliferation of HEPG2 cells in a dose-dependent manner with the IC50 value of 52.7 μmol L-1 and invasion of HEPG2 cells (21.6 %, p = 0.0018) and colony formation of those invaded cells (57...
December 1, 2016: Acta Pharmaceutica
Sadamoto Zenda, Takashi Kojima, Ken Kato, Sachiko Izumi, Taijiro Ozawa, Naomi Kiyota, Chikatoshi Katada, Takahiro Tsushima, Yoshinori Ito, Tetsuo Akimoto, Yasuhisa Hasegawa, Miyuki Kanamaru, Hiroyuki Daiko
PURPOSE: To clarify, in a multicenter, single-arm, phase 2 study (UMIN Clinical Trials Registry no. UMIN000001439), the clinical profile of chemoradiotherapy (CRT) for cervical esophageal cancer. PATIENTS AND METHODS: Patients with operable cervical esophageal cancer, excluding candidates for endoscopic resection, were enrolled. Protocol treatment consisted of CRT and adjuvant chemotherapy (CT). First, patients received concurrent CRT with 5-fluorouracil (5-FU) plus cisplatin (CDDP)...
September 3, 2016: International Journal of Radiation Oncology, Biology, Physics
Feng-Hua Wang, Yun Wang, Zhen-Dong Chen, Jian-Hua Chen, Feng-Zhan Qin, Wen-Qi Jiang, Yu-Hong Li
Recombinant human lymphotoxin-α derivative (rhLTα-Da) is a lymphotoxin-α derivative missing 27 N-terminal amino acid residues. This multicenter phase IIa trial was conducted to evaluate the safety, efficacy and pharmacokinetics of rhLTα-Da with cisplatin (DDP) and 5-fluorouracil (5-Fu) for metastatic esophageal squamous cell cancer (ESCC) and gastric adenocarcinoma (GC). Two different rhLTα-Da doses (10 µg/m(2)/d and 20 µg/m(2)/d) in combination with DDP and 5-Fu were evaluated in this study. The first 6 ESCC and 6 GC patients were given 10 µg/m(2)/d rhLTα-Da followed by DDP (15 mg/m(2)/d) and 5-Fu (750 mg/m(2)/d) on days 1-5...
November 2016: Medical Oncology
Emiliano Calvo, Jean-Charles Soria, Wen Wee Ma, Tao Wang, Rastilav Bahleda, Anthony Tolcher, Diana Gernhardt, Joseph O'Connell, Robert Millham, Nagdeep Giri, Michael J Wick, Alex A Adjei, Manuel Hidalgo
PURPOSE: This phase I, open-label, single-arm trial assessed the safety and tolerability of dacomitinib-figitumumab combination therapy in patients with advanced solid tumors. EXPERIMENTAL DESIGN: A standard 3+3 dose escalation/de-escalation design was utilized. Starting doses were figitumumab 20 mg/kg administered intravenously once every 3 weeks (q3w) and dacomitinib 30 mg administered orally once daily. We also performed an independent study of the combination in patient-derived xenograft (avatar mouse) models of adenoid cystic carcinoma (ACC)...
October 12, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
R L Ferris, J L Geiger, S Trivedi, N C Schmitt, D E Heron, J T Johnson, S Kim, U Duvvuri, D A Clump, J E Bauman, J P Ohr, W E Gooding, A Argiris
BACKGROUND: Treatment intensification for resected, high-risk, head and neck squamous cell carcinoma (HNSCC) is an area of active investigation with novel adjuvant regimens under study. In this trial, the epidermal growth-factor receptor (EGFR) pathway was targeted using the IgG2 monoclonal antibody panitumumab in combination with cisplatin chemoradiotherapy (CRT) in high-risk, resected HNSCC. PATIENTS AND METHODS: Eligible patients included resected pathologic stage III or IVA squamous cell carcinoma of the oral cavity, larynx, hypopharynx, or human-papillomavirus (HPV)-negative oropharynx, without gross residual tumor, featuring high-risk factors (margins <1 mm, extracapsular extension, perineural or angiolymphatic invasion, or ≥2 positive lymph nodes)...
October 11, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Padmanee Sharma, Margaret K Callahan, Petri Bono, Joseph Kim, Pavlina Spiliopoulou, Emiliano Calvo, Rathi N Pillai, Patrick A Ott, Filippo de Braud, Michael Morse, Dung T Le, Dirk Jaeger, Emily Chan, Chris Harbison, Chen-Sheng Lin, Marina Tschaika, Alex Azrilevich, Jonathan E Rosenberg
BACKGROUND: Few effective treatments exist for patients with advanced urothelial carcinoma that has progressed after platinum-based chemotherapy. We assessed the activity and safety of nivolumab in patients with locally advanced or metastatic urothelial carcinoma whose disease progressed after previous platinum-based chemotherapy. METHODS: In this phase 1/2, multicentre, open-label study, we enrolled patients (age ≥18 years) with urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra at 16 sites in Finland, Germany, Spain, the UK, and the USA...
October 7, 2016: Lancet Oncology
Thomas W Lycan, Timothy S Pardee, William J Petty, Marcelo Bonomi, Angela Alistar, Zanetta S Lamar, Scott Isom, Michael D Chan, Antonius A Miller, Jimmy Ruiz
BACKGROUND: Small cell lung cancer (SCLC) is a common lung cancer which presents with extensive stage disease at time of diagnosis in two-thirds of patients. For treatment of advanced disease, traditional platinum doublet chemotherapy induces response rates up to 80% but with few durable responses. CPI-613 is a novel anti-cancer agent that selectively inhibits the altered form of mitochondrial energy metabolism in tumor cells. METHODS: We evaluated CPI-613 with a single-arm, open-label phase II study in patients with relapsed or refractory SCLC...
2016: PloS One
Peter M Waziri, Rasedee Abdullah, Swee Keong Yeap, Abdul Rahman Omar, Ahmad Bustamam Abdul, Nur Kartinee Kassim, Ibrahim Malami, Thiruventhan Karunakaran, Mustapha Umar Imam
ETHNOPHARMACOLOGICAL RELEVANCE: Clausena excavata Burm.f. is used locally in folk medicine for the treatment of cancer in South East Asia. AIM OF THE STUDY: To determine the mechanism action of pure clausenidin crystals in the induction hepatocellular carcinoma (hepG2) cells apoptosis. MATERIALS AND METHODS: Pure clausenidin was isolated from Clausena excavata Burm.f. and characterized using (1)H and (13)C NMR spectra. Clausenidin-induced cytotoxicity was determined by MTT assay...
October 8, 2016: Journal of Ethnopharmacology
Jaime Stella Moses Richardson, Gautam Sethi, Guan Serm Lee, Sri Nurestri Abdul Malek
BACKGROUND: Cancer has been one of the leading causes of mortality in this era. Ruta angustifolia L. Pers has been traditionally used as an abortifacient, antihelmintic, emmenagogue and ophthalmic. In Malaysia and Singapore, the local Chinese community used it for the treatment of cancer. METHODS: In this study, the methanol and fractionated extracts (hexane, chloroform, ethyl acetate and water) of R. angustifolia were tested for its cytotoxicity using the sulforhodamide (SRB) cytotoxicity assay against HCT-116, A549, Ca Ski and MRC5 cell lines...
October 12, 2016: BMC Complementary and Alternative Medicine
Sumanta K Pal, Harry A Drabkin, James A Reeves, John D Hainsworth, Susan E Hazel, Dario A Paggiarino, Jon Wojciak, Gary Woodnutt, Rupal S Bhatt
BACKGROUND: Upregulation of sphingosine-1-phosphate (S1P) may mediate resistance to vascular endothelial growth factor (VEGF)-directed therapies and inhibit antitumor immunity. Antagonism of S1P in preclinical models appears to overcome this resistance. In this phase 2 study, the authors assessed the activity of sonepcizumab, a first-in-class inhibitor of S1P, in patients with metastatic renal cell carcinoma (mRCC) with a history of prior VEGF-directed therapy. METHODS: Patients were required to have clear cell mRCC and to have received treatment with at least 1 prior VEGF-directed agent...
October 11, 2016: Cancer
Florian Schmitt, Heidrun Draut, Bernhard Biersack, Rainer Schobert
Three 3-(3-halo-4,5-dimethoxyphenyl)-1-(2-naphthyl)prop-2-en-1-ones 1 and three structurally related 2-pyrazolines 2 were prepared and assessed in vitro for anticancer activity. The chalcones 1 were antiproliferative with low double-digit micromolar IC50 values against six tumor cell lines whereas the pyrazolines 2 showed low single-digit micromolar IC50 values against this panel. The pyrazolines inhibited ATP-binding cassette efflux transporters of types P-gp and BCRP while the chalcones inhibited selectively BCRP...
September 30, 2016: Bioorganic & Medicinal Chemistry Letters
Minh Tam Truong, Qiang Zhang, David I Rosenthal, Marcie List, Rita Axelrod, Eric Sherman, Randal Weber, Phuc Felix Nguyen-Tân, Adel El-Naggar, André Konski, James Galvin, David Schwartz, Andy Trotti, Craig Silverman, Anurag Singh, Karen Godette, James A Bonner, Christopher U Jones, Adam S Garden, George Shenouda, Chance Matthiesen, Quynh-Thu Le, Deborah Bruner
PURPOSE: To analyze the quality of life (QOL) and performance status (PS) (secondary outcome) in patients with stage III to IV head and neck cancer (HNC) enrolled on a prospective randomized phase 3 trial comparing radiation-cisplatin without cetuximab (CIS) or with cetuximab (CET/CIS). The QOL hypothesis proposed a between-arm difference in Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) total score of ≥10% of the instrument range from baseline to 1 year. METHODS AND MATERIALS: Patients who gave consent to the QOL/PS study completed the FACT-HN, Performance Status Scale for HNC (PSS-HN), and EuroQol (EQ-5D) at baseline through to 5 years...
August 12, 2016: International Journal of Radiation Oncology, Biology, Physics
Canhua Xiao, Qiang Zhang, Phuc Felix Nguyen-Tân, Marcie List, Randal S Weber, K Kian Ang, David Rosenthal, Edith J Filion, Harold Kim, Craig Silverman, Adam Raben, Thomas Galloway, Andre Fortin, Elizabeth Gore, Eric Winquist, Christopher U Jones, William Robinson, David Raben, Quynh-Thu Le, Deborah Bruner
PURPOSE/OBJECTIVE(S): To analyze quality of life (QOL) and performance status (PS) for head and neck cancer (HNC) patients treated on NRG Oncology RTOG 0129 by treatment (secondary outcome) and p16 status, and to examine the association between QOL/PS and survival. METHODS AND MATERIALS: Eligible patients were randomized into either an accelerated-fractionation arm or a standard-fractionation arm, and completed the Performance Status Scale for the Head and Neck (PSS-HN), the Head and Neck Radiotherapy Questionnaire (HNRQ), and the Spitzer Quality of Life Index (SQLI) at 8 time points from before treatment to 5 years after treatment...
July 25, 2016: International Journal of Radiation Oncology, Biology, Physics
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