View clinical trials related to Neoplasm.
Filter by:Background: People who receive an allogeneic hematopoietic stem cell transplant (HSCT) require long-term care at home afterwards. Their caregivers often experience high levels of stress, which can lead to symptoms such as depression, anxiety, poor sleep, fatigue, and difficulties with concentration and memory. Objective: To explore whether a nature-based immersive virtual reality (VR) program helps reduce stress in people who care for HSCT patients. Eligibility: People aged 18 and older who are primary caregivers of HSCT patients. Design: This is a two-phase study. Participants will be enrolled for 4 weeks. They will have 2 clinic visits. Participants will have a physical exam at the beginning of the study. They will be asked to provide a saliva sample in Phase 1, and saliva and blood samples in Phase 2. Participants will be given a VR headset. This is a device that looks like a pair of goggles worn over the eyes. They will be asked to wear the headset for 20 minutes per day. They will see 360 (Infinite) high-definition videos of nature and hear nature sounds. Participants will record the time they spend using the VR headset in a daily diary. They will take surveys with questions about any stress and symptoms they feel once a week. This will take up to 5 minutes. Participants will have a short regular follow-up visit by phone one week after starting their participation. At the end of the intervention study, participants will return for another physical exam. They will give saliva and/or blood samples again. Researchers will also look at the medical records of the HSCT patients; the HSCT patients must consent to this. ...
This is Phase 1/Phase 2, open label, multiple cohort, first-in-human study to evaluate safety, PK, PDy and efficacy of SAR444200 as a monotherapy or in combination with other anti-cancer agents for participants aged at least 18 years with previously treated metastatic malignancies.
This is a Phase1, single-arm study for treatment. This is a prospective multicenter, multinational, open-label study to assess the effect of tusamitamab ravtansine on the QT interval in participants with metastatic colorectal cancer (CRC), nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GEJ) adenocarcinoma for which in the judgement of the Investigator, no standard alternative therapy is available.
This study allows head and neck cancer surgeons to specifically visualize cancerous cells apart from normal healthy tissue. 5-aminolevulinic acid (5-ALA) is a safe and effective FDA-approved agent successfully used by neurosurgeons for FGS of different brain tumors is given to the patients preoperatively. Using specific wavelengths of light as well as specialized magnified lenses the surgeons use this technique to assist in tumor resection.
Primary Objectives: Part 1 (Dose Escalation) - To determine the MTD/maximum administered dose (MAD) of SAR443216 administered as a single agent in participants with HER2 expressing solid tumors and determine the RD(s) for intravenous (IV) and subcutaneous (SC) administration in the dose escalation part. - To determine the safety of SAR443216 after intravenous (IV) and subcutaneous (SC) administration. Part 2 (Dose expansion) • To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression. Secondary Objectives: Part 1 • To assess preliminary clinical activity of single agent SAR443216 after IV and SC administration at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression. Part 2 • To determine the safety of SAR443216. Part 1 and 2 - To characterize the pharmacokinetic (PK) profile of SAR443216 when administered as a single agent after IV and SC (Part 1 only) administration. - To evaluate the immunogenicity of SAR443216 after IV and SC administration. - To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression.
The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization/expansion phase (Part 2). Part 1 is comprised of three sub-parts: SAR444881 administered alone (Sub-Part 1A), SAR444881 administered in combination with pembrolizumab (Sub-Part 1B), and SAR444881 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of SAR444881 per indication are administered in combination with pembrolizumab, cetuximab, and/or carboplatin and pemetrexed (Sub-Part 2A); and a dose expansion part where SAR444881 is administered alone (Sub-Part 2B). In Sub-Part 2A, a two-stage design will be implemented to conduct dose optimization for each indication with combination therapy- Stage 1 (Preliminary Assessment) and Stage 2 (Randomization). Study is non-randomized except Stage 2 of Sub-Part 2A which will use randomization.
Prospective diagnostic study to determine the diagnostic accuracy of preoperative 18F--fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) in detecting local tumor extent, cervical lymph node metastases and distant metastases/secondary primary tumor.
Studies have demonstrated that the use of a procalcitonin (PCT)-guided algorithm in combination with clinical judgment was associated with reduced antibiotic use without impacting mortality or treatment failure. Though several studies have evaluated the use of PCT in critically ill patients, there are limited studies that evaluated PCT in patients with cancer and many of the currently available studies have excluded immune-compromised patients. This is a randomized controlled trial that aims to evaluate the impact of a procalcitonin-guided algorithm on antibiotic utilization in critically ill cancer patients with sepsis. In addition, the study aims to evaluate the predictive value of PCT for predicting mortality and positive cultures.
The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation. The hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases. The primary endpoint is the prevalence of pharmacist interventions among patients who are going to receive an oral targeted therapy or cancer chemotherapy or immunotherapy
The primary objective of this trial is: Part A - To determine the Maximum tolerated dose (MTD) and/or the recommended dose (RD) of BI 891065 monotherapy for further development in Asian patients with advanced solid tumours Part B - To determine the MTD and/or the RD of BI 891065 in combination with a fixed dose of BI 754091 at 240 mg for further development in Asian patients with advanced solid tumours The secondary objectives are: Part A - To document the safety and tolerability, and characterise pharmacokinetics (PK) of BI 891065 as monotherapy in Asian patients with advanced solid tumours Part B - To document the safety and tolerability, and characterise PK of the combination therapy of BI 891065 and BI 754091 in Asian patients with advanced solid tumours