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Neoplasms clinical trials

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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: NCT02045186 Terminated - Clinical trials for Head and Neck Neoplasms

Monitoring of Oral Human Papillomavirus Infection (HPV) in HPV-positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)

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

The purpose of this research study is to determine whether and when patients with human papilloma virus positive squamous cell cancer of the oropharynx treated with radiation and chemotherapy clear their human papilloma virus infection.

NCT ID: NCT02044926 Terminated - IPMN Clinical Trials

Intraductal Papillary Mucinous Neoplasm With Malignant Change

Start date: January 2014
Phase: N/A
Study type: Observational

Purpose: To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012. Hypothesis: According to 2012 consensus guidelines, enhanced solid component and main pancreatic duct size of larger than 10 mm will be significant.

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.

NCT ID: NCT02042989 Completed - Advanced Cancers Clinical Trials

MLN9708 and Vorinostat in Patients With Advanced p53 Mutant Malignancies

Start date: June 27, 2014
Phase: Phase 1
Study type: Interventional

The goal of this clinical research study is to find the highest tolerable dose of the combination of MLN9708 and vorinostat that can be given to patients with advanced solid tumors. The safety of these drugs will also be studied.

NCT ID: NCT02042924 Terminated - Clinical trials for Hematologic Malignancy

Pilot Study of Multi-Modality Imaging in Patients With Hematologic Malignancies

Start date: January 2014
Phase: N/A
Study type: Interventional

This is a pilot sub-study of patients receiving myeloablative transplant using total body irradiation (TBI) or total marrow irradiation (TMI) in their preparative regimen. The objective of this stub-study is to estimate the heterogeneity in cellular proliferation (FLT-PET uptake) as well the heterogeneity in marrow composition distribution (measured using whole body water-fat MRI) using positron emission tomography imaging. This will be used to design future trials as well as to determine the feasibility of PET and MRI imaging.

NCT ID: NCT02042781 Completed - Clinical trials for Advanced Solid Tumours

Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours

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

This Phase Ia study aims to establish the maximum tolerated dose of once-weekly IV infused PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition, the study will explore whether PG545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread.

NCT ID: NCT02042144 Completed - Neoplasms Clinical Trials

Safety and Effectiveness of Regorafenib

Correlate
Start date: April 8, 2014
Phase: N/A
Study type: Observational

This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 1000 patients with metastatic Colorectal Cancer (mCRC) who have been previously treated with other approved treatments for metastatic disease and for whom a decision has been made by the physician to treat with regorafenib according to local health authority approved label. It is the aim of this observational cohort study to further characterize safety and effectiveness of regorafenib in routine clinical practice setting. Healthcare resource utilization in the routine provision of care is becoming increasingly important from a health economics and outcomes research perspective. Therefore, another aim of this observational cohort study is to capture healthcare resource associated with the management of treatment emergent adverse events in the real world setting. The primary objective of this study is to further characterize safety of regorafenib use in routine clinical practice settings. The secondary objective of this study is to assess the effectiveness of regorafenib in routine clinical practice settings as measured by Overall Survival (OS), Progression Free Survival (PFS) and Disease control rate (DCR). Health Related Quality of Life (HRQoL) Data will be collected in applicable countries.