Clinical Trials, Phase II as Topic

Publication Title: 
Clinical Journal of Oncology Nursing

The importance of physical activity for chronic disease prevention and management has become generally well accepted. The number of research interventions and publications examining the benefits of physical activity for patients with cancer has been rising steadily. However, much of that research has focused on the impact of physical activity either prior to or early in the cancer diagnosis, treatment, and survivorship process.

Author(s): 
Albrecht, Tara A.
Taylor, Ann Gill
Publication Title: 
Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology: Official Publication of the International Retrovirology Association

Efficacy trials of candidate HIV-1 vaccines require study populations at high risk of infection who adhere to study protocols and who are willing to participate. Data from HIV-1 antibody-negative men (n = 698) enrolled in Project ACHIEVE in New York City were analyzed to assess willingness to participate in efficacy trials, factors influencing willingness, and the effect on willingness of the June 1994 media events about the decision not to proceed with phase III trials and about breakthrough infections during phase I and II vaccine trials.

Author(s): 
Koblin, B. A.
Avrett, S.
Taylor, P. E.
Stevens, C. E.
Publication Title: 
Investigational New Drugs

In the early drug development process for cancer therapy, several ethical dilemmas result from the use of cancer patients with advanced disease as the subjects of research in clinical trials studying agents of unknown toxicity and/or efficacy. Although several accepted ethical principles guide the behavior of involved physicians and investigators, many of these principles are allowed to be violated in order to achieve the overall goal of clinical research in improving medical care for future patients.

Author(s): 
Daugherty, C. K.
Publication Title: 
Vaccine

There will be a continued imperative to recruit large numbers of healthy volunteers to early phase prophylactic HIV vaccine (PHV) trials. We studied mechanisms associated with participation in two related phase II PHV trials. The most cited reasons for volunteering were altruism and a personal connection to HIV. The most successful recruiting strategies targeted organisations dealing with HIV, health or social issues, or were directed to large audiences through the mass media. However, circulated emails and word of mouth were the most resource-effective approaches.

Author(s): 
Gray, Kimberly
Legg, K.
Sharp, A.
Mackie, N.
Olarinde, F.
De Souza, C.
Weber, J.
Peters, B.
Publication Title: 
Antimicrobial Agents and Chemotherapy

Azithromycin when used in combination with faster-acting antimalarials has proven efficacious in treating Plasmodium falciparum malaria in phase 2 clinical trials. The aim of this study was to establish optimal combination ratios for azithromycin in combination with either dihydroartemisinin or quinine, to determine the clinical correlates of in vitro drug sensitivity for these compounds, and to assess the cross-sensitivity patterns. Seventy-three fresh P.

Author(s): 
Noedl, Harald
Krudsood, Srivicha
Leowattana, Wattana
Tangpukdee, Noppadon
Thanachartwet, Wipa
Looareesuwan, Sornchai
Miller, Robert Scott
Fukuda, Mark
Jongsakul, Krisada
Yingyuen, Kritsanai
Sriwichai, Sabaithip
Ohrt, Colin
Knirsch, Charles
Publication Title: 
Clinical Journal of Oncology Nursing

The importance of physical activity for chronic disease prevention and management has become generally well accepted. The number of research interventions and publications examining the benefits of physical activity for patients with cancer has been rising steadily. However, much of that research has focused on the impact of physical activity either prior to or early in the cancer diagnosis, treatment, and survivorship process.

Author(s): 
Albrecht, Tara A.
Taylor, Ann Gill
Publication Title: 
Journal of Alternative and Complementary Medicine (New York, N.Y.)

OBJECTIVES: To document the chemical and biologic profile of a clinical phase II red clover (Trifolium pratense L.) extract by identifying and measuring the major and minor components visible in the high-performance liquid chromatography-ultraviolet (HPLC-UV) chromatogram and evaluating each compound for estrogenic and antioxidant activity.

Author(s): 
Booth, Nancy L.
Overk, Cassia R.
Yao, Ping
Burdette, Joanna E.
Nikolic, Dejan
Chen, Shao-Nong
Bolton, Judy L.
van Breemen, Richard B.
Pauli, Guido F.
Farnsworth, Norman R.
Publication Title: 
Surgery

BACKGROUND: Neoadjuvant treatment has proven beneficial for many gastrointestinal (GI) malignancies, but no phase III trials have been completed examining this approach in pancreatic cancer. This meta-analysis examines the best available phase II trials using neoadjuvant treatment for resectable and borderline/unresectable pancreatic adenocarcinoma. METHODS: Phase II trials were identified using a MEDLINE search, and the Cochrane Central Register of Controlled Trials from 1960 to July 2010.

Author(s): 
Assifi, M. Mura
Lu, Xuyang
Eibl, Guido
Reber, Howard A.
Li, Gang
Hines, O. Joe
Publication Title: 
International Journal of Cancer. Journal International Du Cancer

Cancer vaccines have recently been shown to induce some clinical benefits. The relationship between clinical activity and anti-vaccine T cell responses is somewhat controversial. Indeed, in many trials it has been documented that the induction of vaccine-specific T cells exceeds the clinical responses observed. Here, we evaluate immunological and clinical responses in 23 MAGE-A3(+) melanoma patients treated with autologous lymphocytes genetically engineered to express the tumor antigen MAGE-A3 and the viral gene product thymidine kinase of the herpes simplex virus (HSV-TK).

Author(s): 
Russo, Vincenzo
Pilla, Lorenzo
Lunghi, Francesca
Crocchiolo, Roberto
Greco, Raffaella
Ciceri, Fabio
Maggioni, Daniela
Fontana, Raffaella
Mukenge, Sylvain
Rivoltini, Licia
Rigamonti, Gianluigi
Mercuri, Santo Raffaele
Nicoletti, Roberto
Maschio, Alessandro Del
Gianolli, Luigi
Fazio, Ferruccio
Marchianò, Alfonso
Florio, Annabella Di
Maio, Michele
Salomoni, Monica
Gallo-Stampino, Corrado
Fiacco, Matteo Del
Lambiase, Antonio
Coulie, Pierre G.
Patuzzo, Roberto
Parmiani, Giorgio
Traversari, Catia
Bordignon, Claudio
Santinami, Mario
Bregni, Marco
Publication Title: 
JOP: Journal of the pancreas

One of the greatest challenges in the treatment of pancreatic cancer remains its inherent lack of beneficial response to cytotoxic chemotherapy. According to the encyclopedic knowledge on herbal medicine regimen and clinical experience accumulated for centuries, traditional Chinese medicine can provide new avenues for alternative treatments of pancreatic diseases. Chinese herbal extracts have been widely used for the treatment of various cancers, but objective information on their efficacy in pancreatic cancer is lacking.

Author(s): 
Saif, Muhammad Wasif
Subscribe to RSS - Clinical Trials, Phase II as Topic