Searching for keyword:"Malignant Neoplasm"

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US Clinical Trial NCT03856060 – NIH – Feb 21, 2019

Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During Clinic Visits: A Randomized Controlled Trial (EHR Study #2)

PRIMARY OBJECTIVES: I. To compare patients' perception of physicians' compassion after they watch the first scripted-video vignettes of physicians: one portraying a physician using a standard electronic health record (EHR) and the other one portray...
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US Clinical Trial NCT02583269 – NIH – Oct 13, 2015

Phase I Study of Muscadine Grape Extract (MGE) in Advanced Malignancy

PRIMARY OBJECTIVES: I. To determine the safety and maximum tolerated dose (MTD) of MGE (muscadine grape skin extract) after 4 weeks of administration for patients with metastatic cancer. Secondary Objectives: I. To monitor adverse events/toxicity...
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US Clinical Trial NCT02419495 – NIH – Apr 14, 2015

Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy Agents in Patients With Advanced Malignancies

PRIMARY OBJECTIVES: I. To establish the safety and tolerability of selinexor when given in combination with standard chemotherapy regimens. SECONDARY OBJECTIVES: I. To determine disease control and progression free survival of selinexor administe...
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US Clinical Trial NCT01531361 – NIH – Feb 6, 2012

A Phase I Trial of Sorafenib (CRAF, BRAF, KIT, RET, VEGFR, PDGFR Inhibitor) or Crizotinib (MET, ALK, ROS1 Inhibitor) in Combination With Vemurafenib (BRAF Inhibitor) in Patients With Advanced Malignancies

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of sorafenib tosylate (sorafenib) or crizotinib in combination with vemurafenib in patients with advanced cancers who progressed on standard the...
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US Clinical Trial NCT01582191 – NIH – Apr 18, 2012

A Phase 1 Trial of Vandetanib (a Multi-Kinase Inhibitor of EGFR, VEGFR, and RET Inhibitor) in Combination With Everolimus (an mTOR Inhibitor) in Advanced Cancer

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) or highest dose level, and the dose-limiting toxicity (DLT) of vandetanib (a multi-kinase inhibitor of epidermal growth factor receptor [EGFR], vascular endothelial growth factor...
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US Clinical Trial NCT02491632 – NIH – Jul 3, 2015

Effects of Physical Activity Plus Short Course of Dexamethasone for Cancer-Related Fatigue in Advanced Cancer

PRIMARY OBJECTIVES: 1. To determine the feasibility, adherence, and satisfaction with physical activity (PA) plus dexamethasone (PA+ DEX). SECONDARY OBJECTIVES: I. To explore the preliminary efficacy of PA+ Hi Dex group (PA for 4 weeks plus high...
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US Clinical Trial NCT01624766 – NIH – Jun 19, 2012

A Phase I Trial of Anakinra (IL-1 Receptor Antagonist) or Denosumab (Anti-RANKL Monoclonal Antibody) in Combination With Everolimus (mTOR Inhibitor) in Patients With Advanced Malignancies

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of anakinra or denosumab in combination with everolimus in patients with advanced cancers who progressed on standard therapy. SECONDARY OBJECTI...
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US Clinical Trial NCT02152254 – NIH – May 21, 2014

Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer: Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT II)

PRIMARY OBJECTIVES: I. To determine whether patients treated with a matched targeted therapy selected on the basis of genomic alteration analysis of the tumor have longer progression-free survival from the time of randomization than those whose tre...
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US Clinical Trial NCT02823652 – NIH – Jun 21, 2016

COMET - Communication and Education in Tumor Profiling: A Randomized Study of Pre-Test Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants With Potential Germline Mutations Identified on Tumor Profiling

PRIMARY OBJECTIVES: I. To evaluate the efficacy of web-based pre-test genetic education (i.e. before receipt of tumor profile results) to increase knowledge (genetic knowledge and knowledge of test benefits and limitations). (Step 1) II. To evalua...
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US Clinical Trial NCT03579446 – NIH – Jun 25, 2018

Levorphanol as a Second Line Opioid in Cancer Patients Undergoing Opioid Rotation: An Open Label Study

PRIMARY OBJECTIVES: I. To determine the proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol on day 10 +/- 1 after rotation. SECONDARY OBJECTIVES: I. To determine the median opioid rotation ratio...
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US Clinical Trial NCT03849742 – NIH – Feb 12, 2019

Ride to Care - A Pilot Study to Investigate the Clinical and Quality of Life Benefit of Eliminating Transportation Barriers for Disadvantaged Cancer Patients Undergoing Ambulatory Palliative Radiotherapy

PRIMARY OBJECTIVES: I. To test whether eliminating transportation barriers for disadvantaged cancer patients can reduce the 6-month rate of unplanned emergency department (ED) visits. SECONDARY OBJECTIVES: I. To test whether eliminating transport...
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US Clinical Trial NCT01525407 – NIH – Jan 31, 2012

Donor Statin Treatment for Prevention of Severe Acute GVHD After Myeloablative Hematopoietic Cell Transplantation

PRIMARY OBJECTIVES: I. To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute GVHD. SECONDARY OBJECTIVES: I. To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible, tolerable and safe. OUTLI...
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US Clinical Trial NCT01697527 – NIH – Sep 28, 2012

Adoptive Transfer of NY-ESO-1 TCR Engineered Peripheral Blood Mononuclear Cells (PBMC) After a Nonmyeloablative Conditioning Regimen, With Administration of NY-ESO-1157-165 Pulsed Dendritic Cells and Interleukin-2, in Patients With Advanced Malignancies

PRIMARY OBJECTIVES: I. To evaluate whether we can safely administer NY-ESO-1 T cell receptor transduced autologous peripheral blood mononuclear cells (PBMCs) (up to 1x10^9 cells) along with an NY-ESO-1 dendritic cell vaccine and low dose IL-2 to pa...
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US Clinical Trial NCT01175837 – NIH – Jul 14, 2010

Short-Term Fasting Prior to Systemic Chemotherapy: A Pilot Feasibility Study

PRIMARY OBJECTIVES: I. Assess the safety and feasibility of short-term fasting prior to administration of chemotherapy. SECONDARY OBJECTIVES: I. Evaluate weight changes in patients who are exposed to short-term fasting prior to chemotherapy. II....
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US Clinical Trial NCT02280161 – NIH – Oct 29, 2014

An Investigation of the Role of Germ-Line Mutations in Cancer Predisposition, Tumor Biology, and Response to Treatment

PRIMARY OBJECTIVES: I. To collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition. II. To investigate the ro...
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US Clinical Trial NCT02054715 – NIH – Jan 31, 2014

Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials

PRIMARY OBJECTIVES: I. To determine the effect of intervention assignment on patients' preparedness for decision making about clinical trial participation. SECONDARY OBJECTIVES: I. To determine the effect of intervention assignment on indicators...
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US Clinical Trial NCT02170350 – NIH – Jun 19, 2014

Use of a Brief Mindful Meditation Practice in Adult Cancer Patients Receiving Radiation Therapy

PRIMARY OBJECTIVES: I. To investigate the feasibility of a clinical trial using a brief mindful meditation practice during radiation therapy. SECONDARY OBJECTIVES: I. To explore the measurable changes in quality of life, fatigue, and mindfulness...
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US Clinical Trial NCT02197091 – NIH – Jul 21, 2014

A Health Services Research Study to Evaluate Communication Effectiveness in Oncology Treatment

PRIMARY OBJECTIVES: I. To assess the feasibility of measuring discrepancies between patient and physician perceptions about the intent of therapy. SECONDARY OBJECTIVES: I. To explore possible correlation between various patient satisfaction indic...
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US Clinical Trial NCT03445572 – NIH – Feb 19, 2018

Feasibility Study of Meditative Practices in Hospitalized Cancer Patients

PRIMARY OBJECTIVES: I. Test the feasibility of the meditation practice. SECONDARY OBJECTIVES: I. Explore the acceptability of meditation in cancer patients through modified Global Symptom Evaluation (GSE) and on day 7 +/- 1 day and day 28 +/- 3 d...
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US Clinical Trial NCT03057639 – NIH – Feb 15, 2017

Adolescent and Young Adult (AYA) Cancers Clinical Model: An Evaluation of the AYA Clinical Care Model by Assessment of Clinical, Psychosocial, and Health Economic Factors Related to AYA Patient Outcomes

PRIMARY OBJECTIVES: I. To provide economic understanding of the AYA at University of Southern California (USC) model of care. (Norris) II. To evaluate the existing AYA at USC program to determine the direct and indirect impact on cost of care. (No...
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US Clinical Trial NCT03656224 – NIH – Aug 27, 2018

Survey of Post-Acute Inpatient Rehabilitation Safety Concerns in the Cancer Population

PRIMARY OBJECTIVES: I. Assess patients' perceptions regarding safety after acute inpatient rehabilitation at discharge and after approximately one month from discharge date. SECONDARY OBJECTIVES: I. Assess patient's perception of factors impactin...
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US Clinical Trial NCT02211196 – NIH – Aug 5, 2014

Implementing Evidence-Based Tobacco Cessation Strategies in Oncology Clinics

PRIMARY OBJECTIVES: I. To assess oncology providers' self-reported need for training on evidence-based tobacco cessation strategies and assess their level of interest in future training on evidence-based tobacco cessation strategies. II. To test t...
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US Clinical Trial NCT01871441 – NIH – Jun 4, 2013

A Two Step Approach to Haploidentical Hematopoietic Stem Cell Transplantation for Patients in Remission From HLA Partially-Matched Related Donors-Effect of Maternal Donors on Outcomes

PRIMARY OBJECTIVES: I. Examine the 1 year disease free survival (DFS) rate of patients with maternal donors or sibling donors who share the maternal haplotype (maternal group) and compare them to patients receiving cells from donors who have points...
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US Clinical Trial NCT01516684 – NIH – Jan 20, 2012

A Randomized, Double Blind Trial of Pediatric Lumbar Puncture Under Sedation/Total Intravenous Anesthesia (TIVA) With and Without EMLA Cream

PRIMARY OBJECTIVES: I. To determine whether the application of a topical anesthetic (EMLA cream) to the LP site will decrease the total dose of propofol administered to pediatric oncology patients who are being sedated for LPs compared to applicati...
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US Clinical Trial NCT03679585 – NIH – Sep 18, 2018

Talking Pictures: An Exploratory Study of a Meaning-Based Social Media Intervention for AYA Cancer Patients

PRIMARY OBJECTIVES: I. To determine the feasibility and acceptability of a 10-week application (app)-based intervention. II. To assess the impact of the intervention on depressive symptoms, spiritual well-being and quality of life. III. To examin...
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US Clinical Trial NCT03941262 – NIH – May 3, 2019

Phase 1, Open-Label, Safety Study of Escalating Doses of Ex Vivo Expanded, Autologous Natural Killer Cells in Participants With Pathologically Confirmed Cancer Refractory to Conventional Therapy

Nine (9) participants, male or female, aged 18 years or older will be enrolled in the study, all of whom will receive "SNK01" without placebo control. There are three (3) subjects in each of the three (3) cohorts. The SNK01 study product will be adm...
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US Clinical Trial NCT03943082 – NIH – May 7, 2019

A Pilot Feasibility Study for Improving Patient Access to Cancer Clinical Trials (iMPACT): A Financial Reimbursement Program for Patients in Cancer Therapeutic Clinical Trials

There are limited financial models that address the economic hardship associated with clinical research participation and how it might restrict clinical research access. The Lazarex Foundation offers a financial reimbursement program (FRP) to help p...
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US Clinical Trial NCT03360799 – NIH – Nov 28, 2017

A Comparison of the Attitudes About Legalization of Marijuana Use for Medical Purposes by Cancer Patients in Two Cancer Centers Located in a Legalized and a Non-Legalized State

PRIMARY OBJECTIVES: I. To compare the proportion of cancer patients' who have a positive attitude about legalizing marijuana for medical purposes between those in a legalized versus (vs.) a non-legalized state. SECONDARY OBJECTIVES: I. To evaluat...
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US Clinical Trial NCT01174264 – NIH – Jul 30, 2010

Evaluation of Food Effect on Pharmacokinetics of GDC-0449, an Inhibitor of Hedgehog Signaling

PRIMARY OBJECTIVES: I. To evaluate the effect of prandial states on the pharmacokinetic parameters of GDC-0449 (vismodegib). II. To evaluate the effect of fat content of meals on the pharmacokinetic parameters of GDC-0449. SECONDARY OBJECTIVES:...
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US Clinical Trial NCT00532064 – NIH – Sep 18, 2007

Early Detection of Cardiotoxicity During Sunitinib or Sorafenib Chemotherapy Using Cardiac Biomarkers

PRIMARY OBJECTIVES: I. To determine if specific biomarkers (troponin I and B-type natriuretic peptide [BNP]) detect cardiotoxicity earlier than standard clinical means in patients receiving sunitinib malate (SU11248) or sorafenib chemotherapy. SEC...
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US Clinical Trial NCT01243333 – NIH – Nov 1, 2010

Multi-tracer PET Assessment of Response in Various Malignancies in Investigational and Recently Approved Therapeutic Agents

PRIMARY OBJECTIVES: I. Provide a reliable and validated cadre of positron emission tomography (PET) imaging derived biomarkers that yield a better understanding of: 1) early clinical benefit from various therapeutic agents in investigational and re...
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US Clinical Trial NCT02444754 – NIH – May 12, 2015

Patient Experience Protocol (PEP): A Pilot Study of Underserved Populations at the Comprehensive Cancer Center of Wake Forest University (CCCWFU)

PRIMARY OBJECTIVES: I. To describe perceived quality of care received in the CCCWFU adult oncology clinics by patients belonging to one of the racial/ethnic minority and underserved populations (Hispanic/Latino, Black/African American, rural, unins...
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US Clinical Trial NCT03808870 – NIH – Jan 10, 2019

A Phase 1, Open-label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Efficacy of NBM-BMX in Asian Subjects With Advanced Solid Tumors

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US Clinical Trial NCT03348137 – NIH – Nov 4, 2017

ORIEN-PROGENY Family History Questionnaire Study: Recognizing Inherited Susceptibility to Cancer

PRIMARY OBJECTIVES: I. Measure the change in uptake of cancer genetic referrals and genetic testing in the ORIEN system of cancer centers implementing the Progeny Family History Questionnaire (FHQ). SECONDARY OBJECTIVES: I. Follow and estimate ut...
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US Clinical Trial NCT02688517 – NIH – Feb 17, 2016

Targeted Genomic Analysis of Human Cancers

PRIMARY OBJECTIVES: I. To obtain blood and tumor tissue for next-generation sequencing and determine the frequency of finding genomic alterations for which there are clinically available (commercially or research based) targeted therapies. Treating...
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US Clinical Trial NCT03578081 – NIH – Jun 25, 2018

Olanzapine With or Without Fosaprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Phase III Randomized, Double Blind, Placebo-Controlled Trial

PRIMARY OBJECTIVES: I. To compare between the two study arms the proportion of patients with no nausea for the overall (0-120 hours post-chemotherapy), acute (0-24 hours post-chemotherapy), and delayed periods (24-120 hours post-chemotherapy) for p...
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US Clinical Trial NCT02243592 – NIH – Sep 16, 2014

Exceptional Responders Pilot Study: Molecular Profiling of Tumors From Cancer Patients Who Are Exceptional Responders

PRIMARY OBJECTIVES: I. To identify molecular indicators in malignant tissues from patients who were exceptional responders on clinical trials or standard systemic treatments using whole exome and/or targeted deep sequencing, as well as potentially...
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US Clinical Trial NCT02590107 – NIH – Oct 27, 2015

The Effect of Oral Supplementation and Improved Nutritional Status on Hematopoietic Stem Cell Transplant Patients

PRIMARY OBJECTIVES: I. To determine if early oral supplementation improves nutritional status, decreases length of hospital stay, and shortens time to engraftment of hematopoietic stem cell transplant (HSCT) participants. SECONDARY OBJECTIVES: I....
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US Clinical Trial NCT01806129 – NIH – Feb 19, 2013

EROS: Engendering Reproductive Health Within Oncologic Survivorship

PRIMARY OBJECTIVES: I. To evaluate the success of the implementation of reproductive health programming (Didactics, Engendering Reproductive Health Within Oncologic Survivorship [EROS] Reproductive Health Assessment and EROS Trial Algorithm) among r...
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US Clinical Trial NCT01884584 – NIH – Jun 19, 2013

Assessment of Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer

PRIMARY OBJECTIVES: I. To validate the use of intraoperative indocyanine green (ICG) for better definition of tumor margins therefore, minimizing the necessity of a second surgical procedure to obtain negative margins. OUTLINE: Patients receive i...
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US Clinical Trial NCT02079181 – NIH – Mar 3, 2014

18F-FMAU for Imaging in Cancer Patients

PRIMARY OBJECTIVES: I. To determine the radiation dosimetry of 18F-FMAU in humans, confirm absence of adverse events in humans from intravenous (i.v.) injection of 18F-FMAU for PET imaging, and characterize the incidence of circulating metabolites...
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US Clinical Trial NCT02310594 – NIH – Nov 13, 2014

The Effect of Radiation Therapy on Tumor Immunity

PRIMARY OBJECTIVES: I. To assess the effect of radiation therapy on tumor immunity. OUTLINE: Samples of blood are collected before, during, and within two weeks after radiation therapy and then stored for analysis of anti-tumor immunity.
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US Clinical Trial NCT03971266 – NIH – May 29, 2019

Precision Performance Status Assessment in Early Phase Clinical Trials

PRIMARY OBJECTIVES: I. To determine if in-office movement trackers identify those patients who are at highest risk for serious adverse events (SAEs) on early and developmental therapeutics (EDT) cancer trials. SECONDARY OBJECTIVES: Secondary obje...
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US Clinical Trial NCT03726294 – NIH – Oct 26, 2018

A Phase 1, Open-label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Efficacy of NBM-BMX in Subjects With Advanced Solid Tumors

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US Clinical Trial NCT03677531 – NIH – Sep 14, 2018

VidRT: Video Distraction During Radiation Therapy to Decrease Use of Pediatric Sedation

PRIMARY OBJECTIVES: I. To determine if the use of video distraction during radiation therapy (VidRT) during radiation for patients ages 3 to 13 decreases the rate of sedation use compared to patients previously treated without VidRT. SECONDARY OBJ...
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US Clinical Trial NCT01556256 – NIH – Mar 15, 2012

Music Video for AYA-Parent Communication and Resilience

PRIMARY OBJECTIVES: I. Compare the efficacy of a Therapeutic Music Video (TMV) intervention with a Therapeutic Music Video plus Parent (TMV+P) intervention on outcomes for adolescents/young adults (AYA) undergoing treatment for high-risk cancer. I...
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US Clinical Trial NCT01432431 – NIH – Sep 8, 2011

Archstone Spiritual Care Demonstration Project: Outcomes for Patients, Families, and Staff

OBJECTIVES: I. To improve the quality of spiritual care provided by palliative care teams. II. To measure the effectiveness of integrating spiritual care recommendations in palliative care at City of Hope (COH) and the impact it has on cancer patie...
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US Clinical Trial NCT01360814 – NIH – May 23, 2011

A Structured Multidisciplinary Intervention to Improve Quality of Life of Patients Receiving Active Oncological Treatment: A Randomized Trial

PRIMARY OBJECTIVES: I. To examine the efficacy of a structured multidisciplinary intervention compared to standard medical care on improving the subject's QOL as measured by the Functional Assessment of Cancer Therapy-General global summary score (...
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US Clinical Trial NCT00678769 – NIH – May 14, 2008

Phase I Study of IMC-A12 (NSC# 742460) in Combination With Temsirolimus CCI-779 (NSC# 683864) in Patients With Advanced Cancers

PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability; and to determine maximum tolerated dose (MTD) of the combination of IMC-A12 (cixutumumab) with temsirolimus in patients with or without biopsiable advanced cancers. II. To evaluate th...
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US Clinical Trial NCT02081794 – NIH – Mar 5, 2014

Tailoring Patient Education to Perceived Risk for Falls in Hospitalized Oncology Patients: A Pilot Study

PRIMARY OBJECTIVES: I. To evaluate the effect of a tailored, nurse-delivered intervention, as compared to the control group, on perceived risk for falls in hospitalized hematology-oncology patients. II. To evaluate the effect of a tailored, nurse-...
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