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NCT ID: NCT02067468 Completed - Cervical Cancer Clinical Trials

Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia

ASCUS-COL
Start date: January 2011
Phase: N/A
Study type: Interventional

Cervical cancer as well cervical preneoplastic abnormalities (CIN2+) are cause by human papillomavirus (HPV) infection. These abnormalities have been historically detected by cervical cytology, but recent evidence shows that HPV testing is superior to cytology to detect cervical lesions that eventually will progress to cancer. Despite evidence, conventional cytology (Pap) remains as a primary screening test in Colombia and HPV test is recommended as a triage test for women with atypical squamous cells of undetermined significance (ASC-US) in settings around the world. Women with ASC-US have low risk to CIN2+ but higher than healthy population, and therefore it is important to provide appropriate clinical management. However, there is no consensus of how to deal women with ASC-US and therefore there are still three strategies for this purpose: 1) immediate colposcopy, 2) repeat conventional cytology at 6 and 12 months and 3) HPV testing. The main objective of this study is to compare the effectiveness and the efficient among the strategies as well as to evaluate the acceptability of the HPV testing in a real-life setting.

NCT ID: NCT02057146 Completed - Clinical trials for Benign Neoplasms of the Pancreas

Endoscopic Evaluation of Premalignant Lesions in the Biliary Tract and Pancreatic Ducts

Start date: October 2013
Phase: N/A
Study type: Interventional

Single operater pancreatico-cholangioscopy is performed through the working channel of conventional duodenoscopes. A visual evaluation of the biliary and pancreatic ductal systems is completed and obvious or suspicious macroscopic lesions are targeted by biopsy forceps. Evaluation of the usefulness of probe based confocal laser endomicroscopy in the evaluation of suspected premalignant lesions in the biliary duct and in the pancreas.

NCT ID: NCT02054806 Completed - Solid Tumor Clinical Trials

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28)

Start date: February 17, 2014
Phase: Phase 1
Study type: Interventional

This study will assess the efficacy and safety of pembrolizumab (MK-3475) administered to participants with incurable advanced biomarker-positive solid tumors that have not responded to current therapy or for which current therapy is not appropriate. The study hypothesis is that administration of pembrolizumab to participants with some types of solid tumors will result in a clinically meaningful response rate.

NCT ID: NCT02054715 Completed - Malignant Neoplasm Clinical Trials

Multimedia Psychoeducation or Print Education in Preparing Cancer Patients for Decision Making About Clinical Trials

Start date: May 1, 2014
Phase: N/A
Study type: Interventional

This randomized clinical trial compares multimedia psychoeducation to print education in preparing patients with cancer for decision making about clinical trial participation. Multimedia psychoeducation includes a digital video disc (DVD) and written materials with a combined focus on knowledge and attitude change, and may be an effective method to help patients prepare for decision making about clinical trial participation. It is not yet known whether a multimedia psychoeducation is more effective than print education in preparing patients for decision making about clinical trials.

NCT ID: NCT02052778 Completed - Breast Cancer Clinical Trials

A Study of TAS-120 in Patients With Advanced Solid Tumors

Start date: July 21, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts: 1. Dose escalation portion to determine the -Maximum Tolerated Dose and/ or Recommended Phase 2 Dose of futibatinib. 2. Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary central nervous system tumors, urothelial carcinoma, breast cancer, gastric cancer. 3. Phase 2 study portion to confirm objective response rate of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).

NCT ID: NCT02047890 Completed - Neoplasms Clinical Trials

Japanese BAY1000394 Monotherapy Phase I Study

Start date: May 19, 2014
Phase: Phase 1
Study type: Interventional

This is an open-label, non-randomized, dose-escalating Phase I study to evaluate the safety, tolerability, pharmacokinetics of BAY1000394 given in a 3 days on / 4 days off schedule in Japanese subjects with advanced malignancies.

NCT ID: NCT02046291 Completed - Clinical trials for Hematologic Malignancies

Safety of Romiplostim (Nplate®) Following UCBT

Start date: April 10, 2015
Phase: Phase 1
Study type: Interventional

This is a single institution, phase I dose escalation study of weekly romiplostim post umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive measurements without transfusion for 7 days. Romiplostim is administered at the assigned dose as 6 weekly injections beginning by day +42 post transplant. Up to 4 dose levels (4, 6, 8, and 10 mcg/kg/dose) will be evaluated with the maximum tolerated dose (MTD) of romiplostim determined by using the Continual Reassessment Method (CRM). The goal of this CRM will be to identify 1 of the 4 dose levels which corresponds to the desired maximum toxicity rate of 20% or less.

NCT ID: NCT02045602 Completed - Clinical trials for Pancreatic Adenocarcinoma

Phase I Dose Escalation Study of Intravenous VCN-01 With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors

Start date: January 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of VCN-01 either administered alone or in combination with Abraxane®/Gemcitabine, and to determine the recommended phase II dose of VCN-01 alone or in combination with Abraxane®/Gemcitabine.

NCT ID: NCT02043756 Completed - Neoplasms Clinical Trials

Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

Start date: August 2011
Phase: Phase 1
Study type: Interventional

The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD), and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.

NCT ID: NCT02043184 Completed - Leukemia Clinical Trials

Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR

Start date: March 2013
Phase: N/A
Study type: Interventional

Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR The goals of this study are to improve adherence to oral chemotherapeutic medications and self-management of symptoms among cancer patients. More than 40 oral agents currently are on the market with projections that in three years 30% of the cancer treatment agents will be delivered in oral form. As a result, patients must assume responsibility for taking medications and self-management of associated side effects. This longitudinal randomized trial tests and compares 'two strategies' for improving patient adherence to their oral cancer medication prescriptions to standard care. Both strategies incorporate symptom management support using an interactive voice response system (IVR) for symptom assessment and a printed evidence-based Medication Management and Symptom Management Toolkit (Toolkit) with helpful strategies and information for symptom management. We will collaborate with NCI Comprehensive Cancer Centers to recruit patients into this study. Recruiters will identify patients as they are prescribed oral cancer medications, present the study to the patient, and ask them to consent to be part of the study. Study Aims Following are the Aims of the study. 1. Cancer patients assigned to the intervention will have greater adherence to their prescribed regimen: a) at week 4 (immediate effect), and b) at weeks 8 and 12 (sustained effect). 2. When compared with patients receiving weekly assessments only, patients receiving weekly assessments plus daily adherence reminders and printed symptom management strategies for 4 weeks will report: lower symptom severity during weeks 2-4 that will be sustained at weeks 5-8, and at 12 weeks. Two exploratory aims are assessed: 1. To test how patient characteristics (age, sex, depression), dose variation, symptom severity, and concurrent infusion therapy moderate the impact of the novel intervention on adherence at 4, 8, and 12 weeks. 2. To test the impact of the novel intervention on dose alterations, emergency department visits and hospital admissions over the 12 weeks in order to support the translation of this system into oncology practices.