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Neoplasm Metastasis clinical trials

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NCT ID: NCT01386606 Completed - Clinical trials for Secondary Hypogonadism

The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

Start date: June 2011
Phase: Phase 2
Study type: Interventional

The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (<350 ng/dL)after 6 weeks of continuous dosing.

NCT ID: NCT01386580 Completed - Breast Cancer Clinical Trials

An Open-label, Phase I/IIa, Dose Escalating Study of 2B3-101 in Patients With Solid Tumors and Brain Metastases or Recurrent Malignant Glioma.

Start date: July 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) of 2B3-101 both as single agent and in combination with trastuzumab. Furthermore, the study will explore the preliminary antitumor activity of 2B3-101 as single agent in patients with with solid tumors and brain metastases or recurrent malignant glioma as well as in patients with various forms of breast cancer with and in combination with trastuzumab in HER2+ breast cancer patients with brain metastases.

NCT ID: NCT01373164 Completed - Pancreatic Cancer Clinical Trials

A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer

Start date: June 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1b: To determine the safe and tolerable dose of galunisertib in combination with gemcitabine in patients with solid malignancy Phase 2a: To compare the overall survival (OS) of patients with Stage II to IV unresectable pancreatic cancer when treated with a combination of galunisertib and gemcitabine with that of gemcitabine plus placebo.

NCT ID: NCT01373047 Completed - Liver Metastases Clinical Trials

CEA-Expressing Liver Metastases Safety Study of Intrahepatic Infusions of Anti-CEA Designer T Cells

HITM
Start date: June 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to collect data on the safety and potential effectiveness of 2nd generation designer T cells delivered into the hepatic circulation in patients with liver metastases expressing the CEA tumor marker. Designer T cells are prepared by collecting white blood cells from the participant, and then modifying these cells in the laboratory so that they recognize the tumor antigen, CEA. These modified cells are then given back into the participant so that they can attack and kill tumor cells. The investigators hypothesize that regional delivery of the designer T cells directly into the hepatic artery will minimize systemic toxicity and optimize the changes for therapeutic effect.

NCT ID: NCT01365715 Completed - Spinal Metastases Clinical Trials

Preoperative Embolization in Surgical Treatment of Spinal Metastases.

Start date: May 2011
Phase: N/A
Study type: Interventional

The main purpose of this study is to assess the efficacy of preoperative embolization in decreasing operative blood loss, decreasing the need for intraoperative transfusion and facilitate surgical resection in metastatic spine surgery. Furthermore the study aims at describing the vascularity in a series of spinal metastasis, and to correlate this with perioperative blood loss.

NCT ID: NCT01360606 Completed - Liver Metastases Clinical Trials

Stereotactic Body Radiation Therapy (SBRT) for Liver Mets

Start date: March 23, 2012
Phase: N/A
Study type: Interventional

This is a phase I dose escalation study. Dose escalation will be via the traditional "up and down" scheme. SBRT: Patients will receive one of the following radiation regimens: - 50 Gy in 5 fractions (10 Gy/fx) delivered over a 2-week period. - 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period. - 75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period.

NCT ID: NCT01360411 Completed - Clinical trials for Secondary Malignant Neoplasm of Lymph Node

Tissue Characterisation by Endoscopic GI-elastography

Start date: January 2007
Phase: N/A
Study type: Observational

In this single centre study we study the use of endoscopic ultrasonography (EUS) combined with elastography in order to separate malignant tissue from benign tissue in and adjacent to the upper gastrointestinal tract.

NCT ID: NCT01358539 Completed - Bone Metastases Clinical Trials

Palliation: the Effect of Education on Pain

PEEP
Start date: September 2010
Phase: Phase 3
Study type: Interventional

Rationale: Although radiotherapy is an effective palliative treatment for patients with painful bone metastases with over 70% responders, pain intensity is not always sufficiently controlled. Recent analyses from the randomized Dutch Bone Metastasis Study on 1157 patients show that during weekly follow up, 35% of the patients remain above a pain intensity level of 4 on a numeric rating scale (range 0-10) despite pain medication. According to the WHO criteria, a pain intensity of 5 or higher prompts treatment. As advised in the CBO guideline 'Pijn bij Kanker' educating patients can improve patient empowerment and thereby pain control. However, the effect of a nurse-led education of patients undergoing palliative radiotherapy for painful bone metastases has not been investigated yet. Objective: This project investigates whether nurse-led pain education in addition to standard care results in better control of pain in patients referred for palliative radiotherapy. Study design: A national multicenter phase 3 study (n=450). Study population: Patients with painful bone metastases referred for short schedule radiotherapy. Intervention: Patients will be randomized between standard care or standard care with the Pain Education Program, a nurse-led pain education. The pain Education Program will be provided on the same day the radiotherapeutic treatment will start. The nurse will first assess the knowledge of a patient based on a structured interview. Thereafter, lacunas will be taught using the 'Pijninstructie Programma' (Pain Education Program). In addition, nurses will telephone patients at regular intervals during follow-up to monitor their needs. Main study parameters/endpoints: The primary outcome of this randomized multicenter study is a decrement of the number of patients whose worst pain intensity remains above 4 at any time during the 12 weeks of follow up with regard to the control group. The secondary outcome is improvement of quality of life. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will fill out the Brief Pain Inventory, the EORTC QLQ-C15-PAL and the EORTC QLQ-BM22 at baseline and, thereafter, weekly for 12 weeks after randomization.

NCT ID: NCT01358110 Completed - Metastatic Cancer Clinical Trials

Emergency Department-Based Palliative Care for Advanced Cancer Patients

Start date: May 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to: 1) identify the palliative care needs of Emergency Department patients with advanced cancer, and determine if these needs can be rapidly assessed in the ED; 2) determine whether early palliative care consultation improves survival, quality of life and other burdensome symptoms and decreases utilization as compared to usual care.

NCT ID: NCT01353625 Completed - Prostate Cancer Clinical Trials

Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.

Start date: April 25, 2011
Phase: Phase 1
Study type: Interventional

The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. The bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients.