Dataset Information

CLIN-ONGOING CLINICAL TRIALS

ABSTRACT: INTRODUCTION: Bevacizumab has been reported to be an effective treatment for symptomatic radiation necrosis and to decrease focal edema around areas of radiation necrosis. We report our preliminary results and ongoing clinical trial of bevacizumab treatment for radiation necrosis. METHODS: Thirteen patients with symptomatic radiation necrosis were treated with bevacizumab. Radiation necrosis was diagnosed according to the patients' clinical courses, magnetic resonance images, and fluoride-labeled boronophenylalanine-positron emission tomography (F-BPA-PET). Lesion/normal (L/N) ratios less than 2.0 and 2.5 on F-BPA-PET were defined as absolute and relative indications for bevacizumab treatment, respectively. The patients were treated with bevacizumab at a dose of 5 mg/kg every 2 weeks, 6 cycles in total. RESULTS: Two patients were excluded from analysis because of adverse events. Eleven patients underwent 3 to 6 cycles of bevacizumab treatment. The median rate of the reduction in peri-lesional edema was 65.5% (range: 2.0% to 81.0%). The Karnofsky performance status (KPS) improved in 6 patients after bevacizumab treatment, and in 5 patients the status did not change. The L/N ratio on F-BPA-PET (P = 0.0084) and the improvement of KPS after bevacizumab (P = 0.0228) were significantly associated with the reduction rate of peri-lesional edema after bevacizumab treatment. CONCLUSION: Bevacizumab is a very effective treatment for radiation necrosis, irrespective of the original tumor histology. F-BPA-PET could be useful for diagnosing radiation necrosis and for making the decision as to whether or not to treat symptomatic radiation necrosis with bevacizumab. The clinical trial “Intra-venous administration of bevacizumab for the treatment of radiation necrosis in the brain” has been approved as Investigational Medical Care System by the Japanese Ministry of Health, Labour and Welfare. This trial has been ongoing since April, 2011.

SUBMITTER: Furuse M

PROVIDER: S-EPMC3488786 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:This review highlights current interventional clinical trials for HIV-associated malignancies (HIVAMs), with emphasis on 4 mechanistic areas: immunomodulatory therapies and gene therapies, including immune checkpoint inhibitors; cytotoxic therapies; novel tumor-targeted and virally targeted therapies in both AIDS-defining and non-AIDS-defining cancers (NADC); and other screening or topical/ablative interventions. A search on ClinicalTrials.gov located 35 trials, including 12 immunomodulatory or gene therapy trials, 6 cytotoxic therapy trials, 10 trials of therapies with tumor or viral molecular targets, and 7 trials evaluating screening interventions or topical or ablative therapies. Study drugs, mechanisms, and outcomes of interest, including future directions, are discussed. Targeted therapies and immunotherapies address not only the tumor but underlying viral oncogens, including possible benefits on HIV-specific immunologic control. The resulting science from the trials listed in this review will provide important translational breakthroughs for people living with HIV (PLWH) and cancer. We highlight disease-specific challenges that could be addressed in future studies, including testing the safety and efficacy of cutting-edge immunotherapy and targeted treatments used in the general cancer population, and improving gaps in knowledge and practice for cancer screening and its treatment, especially in low-resource regions. Additional important considerations include identification of novel therapies for virally mediated tumors that disproportionally present in PLWH, how to treat persons with HIVAM and advanced immunosuppression, and how to comanage both diseases in antiretroviral therapy-naïve persons and those receiving care in settings where supportive therapies for hematologic toxicities and infections are limited. Current and future clinical trials should address needs of both resource-replete and -limited regions, as well as cancers that are uncommon in or respond differently to HIV-negative populations (eg, Kaposi sarcoma or anal cancer), in addition to an increased focus on NADCs not traditionally linked with HIV, such as lung or gastrointestinal tumors.

Project description:The sudden outbreak of 2019 novel coronavirus (2019-nCoV, later named SARS-CoV-2) in Wuhan, China, which rapidly grew into a global pandemic, marked the third introduction of a virulent coronavirus into the human society, affecting not only the healthcare system, but also the global economy. Although our understanding of coronaviruses has undergone a huge leap after two precedents, the effective approaches to treatment and epidemiological control are still lacking. In this article, we present a succinct overview of the epidemiology, clinical features, and molecular characteristics of SARS-CoV-2. We summarize the current epidemiological and clinical data from the initial Wuhan studies, and emphasize several features of SARS-CoV-2, which differentiate it from SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV), such as high variability of disease presentation. We systematize the current clinical trials that have been rapidly initiated after the outbreak of COVID-19 pandemic. Whereas the trials on SARS-CoV-2 genome-based specific vaccines and therapeutic antibodies are currently being tested, this solution is more long-term, as they require thorough testing of their safety. On the other hand, the repurposing of the existing therapeutic agents previously designed for other virus infections and pathologies happens to be the only practical approach as a rapid response measure to the emergent pandemic, as most of these agents have already been tested for their safety. These agents can be divided into two broad categories, those that can directly target the virus replication cycle, and those based on immunotherapy approaches either aimed to boost innate antiviral immune responses or alleviate damage induced by dysregulated inflammatory responses. The initial clinical studies revealed the promising therapeutic potential of several of such drugs, including favipiravir, a broad-spectrum antiviral drug that interferes with the viral replication, and hydroxychloroquine, the repurposed antimalarial drug that interferes with the virus endosomal entry pathway. We speculate that the current pandemic emergency will be a trigger for more systematic drug repurposing design approaches based on big data analysis.

Dataset Information

CLIN-ONGOING CLINICAL TRIALS

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets