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Lung Neoplasms clinical trials

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NCT ID: NCT01137162 Terminated - Lung Cancer Clinical Trials

Clinical and Pathologic Studies of Patients Undergoing Treatment With EGFR Inhibitors

Start date: August 2008
Phase: N/A
Study type: Observational

Cetuximab, erlotinib, and panitumumab are all recently FDA approved epidermal growth factor receptor (EGFR) inhibitors that treat a wide variety of tumor types, such as colon, lung, and head and neck. Blockade of the EGFR results in inhibition of multiple downstream pathways, leading to slowed tumor growth. In addition, these inhibitors may enhance anti-tumor immune responses through uncharacterized mechanisms. While producing significant responses in many settings, EGFR inhibitors also result in significant skin toxicity (rash) in a high percentage of patients. Multiple studies have correlated the presence and severity of rash with clinical response. Unfortunately, severe rash can often lead to dose delays, reductions, or even discontinuation of EGFR inhibitors, thus limiting their efficacy. The mechanism of both the rash and its correlation with tumor response is poorly understood. Skin biopsies display a robust leukocyte infiltrate, but a systematic analysis of the type of infiltrating leukocytes, activation state, or homing receptor expression has not been performed. Chemokines and chemokine receptors control leukocyte trafficking to the skin and other tissue sites, and defined receptor profiles for skin-, gut-, and lung-homing leukocytes are well established. In this study, the investigators propose to evaluate the homing phenotype of leukocytes from peripheral blood and skin biopsies of patients receiving EGFR inhibitors. The investigators will use RNA microarrays to evaluate the expression of chemokines and other key genes regulated in skin during treatment. The investigators will utilize in vitro methods to investigate effects of EGFR inhibitors on imprinting of T cell tissue-specific homing receptors. The investigators will examine correlations among the pathologic data, clinical findings, and tumor response. If validated, peripheral blood evaluation could potentially be used as a predictive indicator for patients receiving EGFR inhibitors. This study may also identify novel targets for limiting skin toxicity while receiving EGFR inhibitors, thus allowing maximal dosing and clinical response from these agents.

NCT ID: NCT01117714 Terminated - Lung Cancer Clinical Trials

Surgical Versus Non-surgical Staging of Lung Cancer

Start date: September 2009
Phase: N/A
Study type: Interventional

About half of all lung cancers are caught after they have spread to nearby lymph nodes. Lymph nodes are small glands found throughout the body that remove bacteria and foreign particles (part of the immune system). A biopsy (tissue sample) can then be sent can be sent to the laboratory for testing. Biopsy results can determine if the cancer has spread (metastases) and to determine the best treatment for a patient with lung cancer. The purpose of this study is to develop a better way to detect lung cancer earlier before it spreads. This study compares the traditional mediastinoscopy/thoracoscopy surgery with the newer combined Endobronchial Ultrasound (EBUS) and Endoscopic Ultrasound (EUS) -guided fine needle aspiration (FNA) to see if either is better for this purpose. Traditional medical practice is to surgically open the chest and biopsy suspicious lymph nodes (called a mediastinoscopy/thoracoscopy). Some medical centers have already started combining the use of EUS plus EBUS as a standard practice for performing needle biopsy of lymph nodes in the chest to stage and treat lung cancer. Volunteers for this study have been diagnosed with known or suspected lung cancer, and will receive one of two choices to determine if their cancer has spread: 1. Traditional Surgical Mediastinoscopy/Thoracoscopy Mediastinoscopy is a surgical procedure that allows physicians to view areas of the chest(including the heart, vessels, lymph nodes, trachea, esophagus, and thymus). An endotracheal (within the trachea) tube is inserted followed by a small incision (cut) in the chest. A mediastinoscope is inserted through the incision to see the organs inside the mediastinum and to collect tissue samples. Mediastinoscopy can be used to detect or stage cancer. Thoracoscopy is a surgical procedure that involves insertion of a thorascope through a very small incision in the chest wall. A thorascope is a thin, tube-like instrument with a light and lens which usually has a tool for removing tissue. This makes it possible to examine the lungs or other structures in the chest cavity, without making a large incision. 2. EBUS combined with EUS-guided FNA EUS involves the use of a special endoscope fitted with an ultrasound processor at its tip. During EUS, images of surrounding lymph nodes can be obtained and a small needle can be guided through the esophagus into suspicious nodes to biopsy lymph nodes in the chest. Other research studies have shown that using EUS to guide needle biopsy of lymph nodes in the chest is equally if not more accurate than surgical biopsy. However, use of EUS for needle biopsy can limit what is seen by the physician and also limit the sampling of lymph nodes in front of the trachea. EBUS involves the use of a small ultrasound scope that is passed through the opening of the trachea and into the airways. EBUS combined with EUS is a less invasive procedure that provides full view of the lymph nodes in the chest area.

NCT ID: NCT01110226 Terminated - Clinical trials for Platinum Responsive Malignancies

Trial Of Cisplatin And KML-001 in Platinum Responsive Malignancies

0805GCC
Start date: April 27, 2010
Phase: Phase 1
Study type: Interventional

This is a Phase I Clinical Trial. Phase I studies are designed to determine the amount of investigational drugs that can be safely tolerated and to define the side effects that limit the dose. The drug administered in this study is KML-001. It is a highly soluble, orally available arsenic agent. It is currently being tested to determine its effects on telomerase activity. In other words, the purpose of this research study is to find the highest dose of KML001, that can be given without causing severe side effects when it is combined with a standard, commercially available anti-cancer drug called cisplatin.

NCT ID: NCT01108666 Terminated - Clinical trials for Non Small Cell Lung Cancer

Proton Beam Radiation With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III Non Small Cell Lung Cancer (NSCLC)

Start date: March 2010
Phase: Phase 2
Study type: Interventional

Seventy two patients are being asked to take part in this research study because they have been diagnosed with Stage IIIA or IIIB non-small cell lung cancer (NSCLC). This study is being done to determine the highest safe dose of proton beam radiotherapy and/or study drug (called Nelfinavir) that can be given with concurrent chemoradiotherapy to patients with cancer without causing bad side effects; and to develop biomarker for clinical outcome. This study will be done in two phases. In the first phase, feasibility will be established. We will follow patients treatment courses and record side effects at the standard proton radiation dose that can be given together with Cisplatinum + Etoposide or Carboplatin + Paclitaxel. In the second phase, we will see if it is possible to increase the total proton radiation dose or study drug without increasing the number of bad side effects while treated together with chemotherapy drugs.

NCT ID: NCT01090830 Terminated - Clinical trials for Non-Small-Cell Lung Carcinoma

Safety and Efficacy of Belinostat When Used With Standard of Care Chemotherapy for Untreated Non-small Cell Lung Cancer

HCH003
Start date: April 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to establish the safest dose of the investigational medication Belinostat that can be administered with a standard of care chemotherapy regimen of bevacizumab, carboplatin, and paclitaxel. Further study will examine the short and long-term effect (up to 2 years) of this medication on participant's disease status and overall survival.

NCT ID: NCT01077492 Terminated - Lung Cancer Clinical Trials

Virtual Bronchoscopy Transbronchial Needle Aspiration(TBNA): a Proof of Concept Study

Start date: April 2010
Phase: N/A
Study type: Observational

The purpose of this study is to determine wether CT-PET virtual bronchoscopy guided transbronchial needle aspiration is suitable for the investigation of mediastinal lymph nodes which is needed for correct staging of lung cancer.

NCT ID: NCT01071434 Terminated - Lung Cancer Clinical Trials

Feasibility of Using Real-time Cine-MRI for Treating Moving & Deforming Tumors

Start date: February 2009
Phase: N/A
Study type: Observational

This study aims to investigate and optimize imaging sequences and parameters of rapid real-time MRI in order to obtain adequate guidance for accurately and precisely delivering radiation to moving abdominal and thoracic tumors.

NCT ID: NCT01064050 Terminated - Clinical trials for Carcinoma, Non-Small-Cell Lung

Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence in Lung Cancers

SPOC
Start date: November 2008
Phase: Phase 4
Study type: Interventional

A tumoral obstruction of the main stem bronchus is frequently observed in the follow-up of lung cancers with a high impact on survival and quality of life of these patients. The endoluminal resection of these tumors through interventional bronchoscopy can remove the tumor but fails to prevent the recurrence. A stent insertion could achieve this goal but this option was never proved in a prospective protocol. The aim of this study is to analyze the impact of stent insertion on the survival without symptoms of bronchial obstruction in patients treated for their cancer with and without a first line treatment (chemo-radiotherapy or chemotherapy). The patients will be included after resection of the endoluminal symptomatic tumoral obstruction. We will test the effect of the silicone stent insertion ( from NovatechR ) by comparing a stent arm (170 patients with stent insertion) with a control arm (170 patients without stent). The inclusion period will last 3 years with one year of follow-up for each patient. The one-year survival without symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone) will be the main endpoint. All patients without symptomatic recurrence at one year will be controlled endoscopically. Survival and stent tolerance will be studied as secondary endpoints. All endoscopic events will be depicted on photographs or videos. Each endoscopical situation (before and after resection, recurrence or side effects of stents) will be analyzed and registered by an independent committee of 3 international experts.

NCT ID: NCT01060514 Terminated - Clinical trials for Metastatic Breast Cancer

Pazopanib + Vinorelbine in Non Small Cell Lung Cancer (NSCLC) and Breast Cancer

Start date: February 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the highest dose of Vinorelbine and Pazopanib that can be given together without causing severe side effects. Also, this study will evaluate what effects (good and bad) that the treatment has on patients and their cancer.

NCT ID: NCT01058759 Terminated - Clinical trials for Non-small Cell Lung Cancer

Taxotere-Enoxaparin-(ENOXA)-Study

Start date: November 2009
Phase: Phase 3
Study type: Interventional

Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as single therapy or in combination with Enoxaparin in patients aged older than 18 years with locally advanced or metastatic non-small cell lung cancer (stadium IIIb/IV), a phase III study. Study hypothesis: Increase of progressive free survival from 5 to 7.5 months.