View clinical trials related to Cancer.
Filter by:This is a protocol to facilitate on-site calibration of the technical aspects of the Siemens Biograph mMR (molecular MR) Positron Emission Tomography-Magnetic Resonance (PET-MR) scanner and the 3T Siemens Vida MR scanner at the Cedars-Sinai Medical Center (CSMC) Biomedical Imaging Research Institute (BIRI) Research Imaging Core after scanner installation. The mMR is a FDA-approved standard clinical device (non-experimental) and will be used in accordance with clearance and approval from the FDA. The Vida is a state-of-the-art FDA approved scanner and will be clinically licensed within a short time.
This is a Phase Ib, open-label, dose-escalation study to determine the Maximal tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) for the combination of afuresertib and paclitaxel in subjects with recurrent HER2-negative gastric cancer, and further assess safety and preliminary efficacy of combination at the RP2D. Afuresertib had showed synergistic activity when combined with paclitaxel in vitro and in vivo models of gastric cancer. Dose escalation will continue until the MTD is established. The dose schedule is once daily (QD) dosing for afuresertib and intravenous (IV) infusion for paclitaxel Dose escalation in Part 1 will follow the 3 + 3 cohort design. A sequential approach will be conducted to explore the optimal paclitaxel regimen (weekly or 3weekly schedule) when combined with afuresertib. The dose escalation will be started from Cohort A (afuresertib combined with weekly paclitaxel regimen at 80 milligram (mg)/meter (m)^2 day1, 8,15, every 4 weeks (q4w). The starting dose in Cohort A will be 125 mg afuresertib QD. Once its MTD is identified, and then the study will move to dosing Cohort B (afuresertib combined with 3 weekly paclitaxel regimen at 175 mg/m^2 day1, every 3 week (q3w). The starting daily dose of Cohort B will be 25 mg less than the MTD dose from Cohort A for afuresertib. If it is tolerated, then the dose escalation schedule will be followed in Cohort B until the MTD in this Cohort is reached. If the starting dose is not tolerated, then dose de-escalation will be explored until the MTD in this Cohort is reached. Once two dimensions of the MTD are achieved, then the optimal regimen for paclitaxel and MTD for afuresertib combined with paclitaxel based on the toxicity profile will be identified. The combination regimen at the RP2D selected following Part I will be further investigated in its efficacy and safety in the Part II Expansion Cohort. Once a combination dose regimen for Part 2 has been determined, at least 20 and up to 40 subjects will be enrolled at the dose regimen selected following Part I. Overall response rate (ORR) will be evaluated using a Green-Dahlberg design. The design consists with one interim analysis. If less than 3 responses are observed in the initial 20 subjects, enrollment will be terminated due to futility; otherwise, the study will continue to meet the planned sample size of 40 subjects.
The purpose of this study is to determine intratumoral concentration of kinase inhibitors upon 2 weeks of treatment in tumor tissue (in the brain) of patients with high-grade gliomas (HGG).
This study will enroll specimens from subjects diagnosed with various cancers and who have either: 1. RETROSPEFCTIVE / ARCHIVAL SAMPLES already undergone surgical resection of their tumor and have one or more formalin fixed and paraffin embedded (FFPE) blocks on file within the local (or affiliated) pathology archive (replicate blocks from same tumor) or blocks no longer required to be maintained on file - discard blocks, or 2. PROSPECTIVE SAMPLES are scheduled to undergo surgical treatment and who prior to scheduled surgery, provide informed consent and donate a 10-20 ml blood sample. After surgery, surplus tissues (including tumor and adjacent normal tissues) not required for diagnosis will be collected. Subject clinical information will be collected, including basic demographic information, medical history, current cancer history and treatment. A final pathology report will be obtained for each subject's surgical specimen. In some instances, and based on the cancer indications required, longitudinal data may also be collected at a frequency of every 6 months to once per year. Longitudinal data will include information on study subject survival and disease recurrence.
The purpose of this study is to compare nurse-led care coordination for persons receiving cancer chemotherapy treatment incorporating mobile health technology to nurse-led care coordination without any mobile health enhancements.
This open-label, 2-part Phase I/ randomized Phase II multi-center study is conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of afuresertib in combination with carfilzomib versus carfilzomib alone, in subjects with relapsed/refractory MM. Part 1 will evaluate 2 dose levels (125 milligrams [mg] and 150 mg of afuresertib) in 16 subjects (approximately 8 in each parallel arm) to determine an optimal dose of afuresertib for administration in combination with carfilzomib in Part 2. If neither of these dose levels are tolerated, an additional dose level of 100mg of afursertib in combination with carfilzomib may be explored in approximately 8 additional subjects. Part 2 was to investigate the safety, and clinical activity of the combination of afuresertib with carfilzomib (determined in Part 1) compared to carfilzomib alone, in approximately 100 subjects (50 in each parallel arm), however the study was terminated after the discontinuation of the single subject following the transition of the afuresertib development program from GSK to Novartis. The reason for the study termination is that the protocol defined study treatment was no longer aligned with the evolving standard of care.
The investigators hypothesise that cancer patients on systemic anticancer therapy can measure a home blood count, temperature, record qualitative data and transfer the results electronically to the hospital clinical team. A low neutrophil blood cell count (neutropenia) can be a dose-limiting toxicity of systemic anti-cancer therapy (SACT) and can be life-threatening when complicated by sepsis. Neutrophil count is usually obtained by venepuncture by a health-care professional. The Minicare H-2000 is a new device which facilitates home self-testing of blood count, temperature and symptoms. The four components are i) blood count recorder using a capillary sample obtained via finger-prick ii) Bluetooth linked thermometer iii) tele-hub collecting patient-reported outcomes and iv) secure communication through the 3G network. The investigators propose a single-centre, non-randomised feasibility study to test the process of patients on chemotherapy using the Minicare H-2000 to deliver self-tested blood count readings, temperature and qualitative data electronically to the hospital clinical team. The aim is to test training of patients to use a finger-prick method of obtaining blood count, patient ability to perform the test, retention of training, the ability of the Minicare H-2000 to facilitate the data transfer and to test the secondary care interface. This study will provide preliminary data on the potential of Minicare H-2000 to prevent wasted hospital journeys when the blood count has not recovered sufficiently for subsequent SACT cycles. The investigators intend to obtain informed consent to recruit between 30 to 80 patients to this study which will be performed in addition to current local standard of care. This study enables identification of suboptimal areas of the process prior to investigating the application of the minicare H-2000 within oncology to improve the clinical patient pathway. The investigators ongoing intentions are to trial the use of the Minicare H-2000 to reduce frequency and severity of neutropenic complications, prevent wasted hospital journeys and hospital resources, reduce non-elective hospital admissions and personalise delivery of SACT.
At present, there are no established treatments for depression or anxiety in adolescents with cancer, creating an important clinical and research gap. Fortunately, there is now substantial evidence documenting the efficacy of psychotherapy in the treatment of depressed and anxious adolescents in the general population.
In response to Program Announcement (PA)-09-164, "NIH Exploratory/Developmental Research Grant Program (R21) a randomized pilot study testing the efficacy of SWIFT: Social Work Intervention Focused on Transitions among at-risk older adults following hospital discharge to home. This study is drawn from several observations. First, transitions between care settings create elevated risk for poor outcomes and for readmission among older adults leaving the hospital for home largely due to fragmented care and poor communication. Next, while few studies exist that test methods to improve transitions, those available are largely medically focused, using a nurse or advanced practice nurse in their approach. Although evidence exists to support the effectiveness of these models, few have been replicated and none have been integrated into standard health care practice. This may be attributed to several factors including the availability of the needed staff, the lack of existing structures to support these roles, and the costs of implementing these interventions. Finally, a social work driven intervention may provide a replicable mechanism for bridging medical care, addressing psychosocial needs as well as medical needs, and improving linkages with community services while reducing care duplication. This study aimed to test a structured social work transition intervention model to reduce rates of hospital readmission and medical service use while improving patient satisfaction with the care transition process. A randomized pilot study was used to test a social work transitions model designed to improve care provided to frail older adults being discharged from the hospital to return to the community. Eligible patients consenting to participate (n=181) were randomly assigned to either the social work transitions model intervention or usual care. This project was conducted at Huntington Hospital, a 525-bed, nonprofit, community hospital located in Pasadena, California. In an average year, Huntington Hospital has approximately 10,000 older adults discharged from their facility, 44% of who are 80 years old or older. Those randomized to the intervention arm received up to six sessions from the social worker, at least one provided in the home. The social work intervention was designed to overcome common problems following hospital discharge including medication review, discussion and planning around discharge instruction, assistance in scheduling follow up appointments, assessments of psychosocial and other support service needs and provision of linkages to address those needs. Outcomes were measured three and six months following arrival at home, with an interim measure of satisfaction at 10 days following arrival at home, with measures including patient level of depression, pain, physical functioning, self-efficacy with disease management, and medical service use.
The investigators plan to compare standard patient navigation with an enhanced navigation partnered with the Medical Legal Partnership | Boston (MLP) to determine if assessing legal needs of newly diagnosed cancer patients in addition to other barriers to care leads to better clinical outcomes.