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221 active trials for Neoplasms

A First in Human Study of AdAPT-001 in Subjects With Refractory Solid Tumors

This is the first clinical trial of AdAPT-001 for the treatment of cancer. AdAPT-001 is an oncolytic virus that is injected directly into the tumor. The purpose of this study is to find out the highest dose of AdAPT-001 that is safe and tolerable. This is the first step in studying whether it can be used to treat others with cancer in the future.

Start: March 2021

Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy

Cancer cachexia is a multi-factorial syndrome defined by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment. There is an urgency for improving management, but there is no consensus on the optimal treatment for cancer cachexia. Several single therapies for cancer cachexia have been examined in clinical trials, with disappointing overall results. As multiple factors are responsible for the development of cachexia, it has been argued that optimal cachexia interventions should target all components: multimodal therapy for a multimodal problem. The overall aim of this study is to early prevent the development of cachexia rather than treatment late in the disease trajectory. From a patient perspective a short term effect will be to improve physical and psychological function, to reduce symptom burden and to improve survival. In other words live a longer and better life during and after chemotherapy. Direct effects of the cachexia intervention are expected to be reduction of weight and muscle loss, and improved physical activity and quality of life.

Start: April 2015

Natural Killer Cell (CYNK-001) Infusions in Adults With AML

This study will find the maximum tolerated dose or the maximum planned dose of CYNK-001 which contains natural killer (NK) cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given after lymphodepleting chemotherapy. The safety of this treatment will be evaluated, and researchers want to learn if NK cells will help in treating acute myeloid leukemia.

Start: March 2020

Family Caregiver Ambassador Support for Family Caregivers of Patients With Hematological Disease

Background: Family caregivers are of great importance to patients undergoing treatment for cancer, but at the same time, caregivers themselves are in great risk of distress and high symptom burden which affects their quality of life and ability to support the patients. Within hematology the context of treatment from hospital to home has changed in the past years placing more responsibilities on caregivers. Finding new ways to support caregivers within the health care context is important. Psychosocial interventions can enhance emotional well-being, and peer to peer support model has been found to be effective for patients coping with cancer. There is a lack of knowledge and evidence of the feasibility and effects of a peer-to-peer support in caregivers within hematology. Aims: The study aim to examine the feasibility and safety of Family Caregiver Ambassador Support in caregivers of newly diagnosed patients with hematological disease, and to examine if it has an effects on symptoms and psychological wellbeing in both family caregivers and ambassadors. It is hypothesized that the family caregiver peer to peer support model will reduce symptoms of burden, reduce concerns and improve emotional and social well-being in family caregivers. Design and methods: The study is a one arm feasibility intervention trial with family caregivers (n=30) and family caregiver ambassadors (N=20). Family Caregivers will be recruited at the Department of Hematology, Rigshospitalet. Family Caregivers will be partnered with a family caregiver ambassador. The intervention will be carried out in a 12-week period and consist of telephone and/or e-mail contact and face to face meetings with one follow-up at three months. Both caregiver and ambassador data will be collected at baseline, post intervention and follow-up 3 months. Implication: The study has the potential to be a new model of care incorporated in the clinical setting to strengthen the support system for caregivers and may likely be tailored to other cancer groups and caregivers.

Start: October 2019

Investigation of a Therapeutic Vaccine (ACIT-1) in Cancer

This study evaluates four different doses of ACIT-1 for safety and for the ability to raise effective anti-cancer immune responses in patients with pancreatic and other cancers. Approximately half of the patients will have pancreatic cancer and the other half will have other cancers.

Start: April 2017

Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition

Type of study: Pilot / phase I trial Study purpose To assess the impact of a dietary intervention during radio(chemo)therapy (RCT) on body composition changes Trial Treatment Patients will be split into a control group and intervention group 1. If willing to undertake a ketogenic diet for the duration of radiotherapy, patients are entered into intervention group 2. Group 1: On irradiation days irradiation after overnight fast + ketogenic breakfast consisting of 50-250 ml betaquik® (vitaflo, Bad Homburg, Germany) and 10g MyAmino (dr. reinwald healthcare gmbh + co kg, Altdorf, Germany). Group 2: Complete ketogenic diet plus 10g MyAmino/day Control: No dietary intervention. All groups: Weight measurements and bioimpedance analysis (BIA) once per week, routine blood parameters and quality of life (QoL) questionnaire before, during and after RCT Endpoints Primary: Feasibility of the dietary intervention during RCT, measured by dropout rates Changes in body weight BIA phase angle and quantities derived from BIA variables Secondary: QoL Toxicities Blood parameters Grade of regression at time of surgery in case of rectum carcinomas Inclusion criteria One of the following tumor entities: Breast carcinoma Rectum carcinoma Head & Neck Cancer Histological confirmation of malignancy Signed written informed consent Karnofsky index ? 70 Age between 18 and 75 years BMI between 18 and 34 kg/m^2 Exclusion criteria Palliative patients, in particular with metastasis Type I diabetes Pregnancy Pacemaker and other metallic parts within the body Known defects in enzymes necessary for ketogenesis, ketolysis, fatty acid oxidation or gluconeogenesis Unable to speak or understand German Cognitive impairments or psychological disorders Renal insufficiency Planned accrual 15 patients with colorectal and mammary tumor plus 5 patients with H&N cancer in intervention group 1 15 patients with colorectal and mammary tumor plus 5 patients with H&N cancer in control group Minimum 5 patients of each tumor entity in intervantion group 2 Total: n ? 85 patients Study procedure Inclusion and full written informed consent. Baseline BIA measurement and blood work RCT with weekly BIA assessments; at least one blood withdrawal ± concurrent dietary intervention Final BIA measurement and blood work after radiotherapy Follow up For rectal carcinoma: Regression at time of surgery (c and p)

Start: June 2015

Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer

The INTERACT study is a nation-wide, population-based randomized controlled trial to investigate the effects of 6-month integrative neuromuscular training during anti-cancer treatment on lower body muscle strength, metabolic syndrome, various measures of physical function, physical activity, days of hospitalization, health-related quality of life and health behavior in children and adolescents with cancer. The increased insight derived from this study will impact the development of pediatric exercise oncology and be of high relevance to a broad group of children and adolescents with severe chronic illness. The study is based on the overarching hypothesis, that structured integrative neuromuscular training initiated immediately after diagnosis will be effective in preventing deficits in neuromuscular function, limit long-term cardio-metabolic morbidity and found long-standing improvements in physical activity behavior. To maintain adherence and motivation throughout a 6-month training intervention, weekly supervision of the training is needed. For this study, it is hypothesized that a supervised exercise intervention, in addition to a motivational counseling intervention and usual care, will improve muscle strength compared with unsupervised home-based training (active controls).

Start: January 2021

A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) and maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of JNJ-70218902 RP2D(s) in Part 2.

Start: July 2020

Pharmacokinetic and Safety Study of MRX-2843 in Adults With Relapsed/Refractory Advanced and/or Metastatic Solid Tumors

This first-in-human open-label, dose escalation study is designed to evaluate the safety, tolerability, and PK of MRX-2843 in subjects with relapsed/refractory advanced and/or metastatic solid tumors.

Start: May 2018

Mirtazapine in Cancer-related Poly-symptomatology

Multicenter, prospective, randomized, controlled trial based on a mixed-method methodology using parallel groups, of oral mirtazapine (intervention) compared with oral escitalopram (control), with a 56 days follow-up. Improvement of the Global health Status (issued from the EORTC-QLQ-C30 (Quality of Life Questionnaire)) will be used as the primary outcome on day 56. Semi-structures interviews will be performed on a purposive sample for qualitative analysis. The 418 participants will be followed-up at day 7, 14, 28 and 56 for a 56 days period. A sub-group of participants will be invited to take part into qualitative interviews at baseline and day 56. Recruitment of participants to the qualitative part will be based on a purposive sampling.

Start: March 2021

Phase 1 First Time in Humans (FTIH), Open Label Study of GSK3745417 Administered to Subjects With Advanced Solid Tumors

This is a Phase I, FTIH, open-label, repeat-dose, non-randomized, multicenter, multi-country study to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered intravenously (IV) alone (Part 1) or co-administered (Part 2) with pembrolizumab in subjects with refractory/relapsed solid tumors. Each part consists of a dose escalation phase and a cohort expansion phase. In Part 1A, escalating doses of GSK3745417 will be evaluated as guided by the Neuenschwander-continuous reassessment method (N-CRM) approach. In Part 2A, escalating doses of GSK3745417 in combination with 200 milligrams (mg) pembrolizumab will be evaluated as guided by the N-CRM approach. In Part 1B and 2B, subjects will receive a single dose level of GSK3745417 as identified based on data from Part 1, either alone or in combination with pembrolizumab. A total of approximately 300 subjects will be enrolled in this study, approximately 120 for dose escalation cohorts, and approximately 180 in the expansion cohorts.

Start: March 2019

A Study of CC-95251, a Monoclonal Antibody Directed Against SIRP?, in Subjects With Advanced Solid and Hematologic Cancers

Study CC-95251-ST-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Parts B and C), first-in-human clinical study of CC-95251 in subjects with advanced cancers.

Start: February 2019

Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Subjects who received at least one GM T cell infusion, will be asked to roll-over to this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

Start: June 2018

Dietary Patterns and Health Outcomes (Cardiovascular, Metabolic, Endocrine, Neurological, Skeletal Muscular, Cancer)

To study, prospectively, the association between dietary patterns and risk of health outcomes (cardiovascular, metabolic, endocrine, neurological, skeletal muscular, cancer) in cohort study of 116,671 women age 24 to 44 years at baseline in 1989 (the Nurses' Health Study II; NHS II).

Start: January 1989

A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors

This is a Phase 1 study which consists of 2 parts; Dose Escalation part and Expansion part. The dose escalation part is open-label, and evaluates safety, preliminary efficacy and PK of single-agent talazoparib in sequential cohorts of adult patients with advanced solid tumors who are resistant to standard therapy or for whom no standard therapy is available. In the dose escalation part, up to 18 (minimum 3) patients are expected to be enrolled depending on the observed DLTs. The expansion part is designed to assess the efficacy, safety and PK of single-agent talazoparib at RP2D determined in the dose escalation part in adult patients with locally advanced or metastatic breast cancer who have deleterious or suspected deleterious germline BRCA1 or BRCA2 mutations. In the expansion part, a minimum of 17 patients will be enrolled evaluable for the primary endpoint.

Start: November 2017

Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives

This study will investigate the drug-drug interactions (DDIs) between rucaparib and oral rosuvastatin (Arm A), and between rucaparib and oral ethinylestradiol and levonorgestrel (Arm B), with rucaparib as a perpetrator.

Start: May 2019

A Dose Escalation Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors

First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients with Advanced/Metastatic Solid Tumors

Start: December 2018

Anticoagulation in Patients With Venous Thromboembolism and Cancer

This study is a retrospective analysis of observational cohorts using data from prospectively collected administrative/claims data to investigate treatment patterns,healthcare resource utilisation (HCRU), direct and indirect costs (where feasible), and safety and effectiveness outcomes in patients with VTE and active cancer or patients with VTE and history of cancer who initiate anticoagulant treatment with a VKA, LMWH or NOACs.

Start: December 2020

Efficacy Study of Chemoradiotherapy With or Without Paclitaxel in Squamous-cell Anal Carcinoma Patients

The purpose of this study is to determine whether the combination of paclitaxel, capecitabine, mitomycin and intensity-modulated radiotherapy is more effective than the standard combination of capecitabine, mitomycin and intensity-modulated radiotherapy (IMRT) in patients with squamous-cell anal cancer.

Start: January 2016

Intermittent Fasting and CLL/SLL

What are the investigators trying to do? By most measures, humans consume more food than needed. Over several decades, overconsumption has led to an increase in a number of diseases, including cancer. What if this could be reversed, or slowed down, by fasting? Would that improve how cancer patients respond to chemotherapy? Could simply changing eating patterns to reduce overall intake be a way to prevent and/or manage cancer? All of these are important questions and the investigators are undertaking a new initiative to study how nutrition and dietary behaviours affect cancer patients. Fasting: A way to improve overall health and increase our defenses to cancer Fasting in various forms has been shown to have a number of health benefits. Intermittent fasting, or time restricted feeding, has been shown to reverse or improve various diseases such as diabetes, heart disease and metabolic syndrome, decrease the risk of cancer, and significantly extend the life of an individual. In previous studies, fasting was well-tolerated with notable improvements in energy levels, sense of well-being, and sleep quality. In cancer patients, clinical trials have demonstrated intermittent fasting to lessen some of the short-term side effects of chemotherapy such as nausea, fatigue, and sleep quality. How fasting alters the course of cancer or improve immune defenses is not yet known but may be an alternative way to treat or manage cancer. The study plan The investigators plan to examine the effects of intermittent fasting (time restricted feeding) in patients with chronic lymphocytic leukemia (CLL). CLL is the most common chronic leukemia and is presently incurable. The advantage of choosing this patient population is that the cancer is easily assessed with a blood test measuring the amount of cancerous white cells (lymphocytes). Patients who consent to participate in this study will, through the support of an oncology dietitian and after a period of transition, split their daily feeding into a fasting period and a non-fasting period. This regime is as simple as skipping or having a late breakfast. At this time, participants will not be required to limit their total caloric intake. What is required from the participant? The investigators will assess whether intermittent fasting reduces the cancer by measuring the lymphocyte count in the blood over a period of 3 months. Study participants will complete questionnaires to help determine if fasting causes any change in their quality of life. The effects of intermittent fasting on a cancer control system called autophagy, as well as its effects on inflammation will be studied in the Deeley Research Centre laboratory at BC Cancer. What is the short- and long-term impact? In the short-term, if intermittent fasting can have an effect cancer lymphocyte count or on autophagy, then investigators will proceed with further studies to try and optimize the effects of intermittent fasting. In the long-term, this study is expected to be the first-ever to shed light on how intermittent fasting may be linked to cancer survival and/or growth. If true, this will open up new avenues to re-evaluate the inclusion of diet into cancer treatment protocols.

Start: February 2021