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Head and Neck Neoplasms clinical trials

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NCT ID: NCT00978250 Completed - Breast Neoplasms Clinical Trials

A Multi-Histology Phase II Study of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine (FdCyd + THU)

Start date: August 20, 2009
Phase: Phase 2
Study type: Interventional

Background: - Two experimental drugs, FdCyd (also called 5-fluoro-2'-deoxcytidine), and THU (also called tetrahydrouridine), are undergoing trials to test their effectiveness in treating cancer that has not responded to standard therapies. FdCyd is thought to work by changing how genes work in cancer cells. THU does not have any anticancer effects on its own, but it helps keep the other drug, FdCyd, from being broken down by the body. - These drugs are being tested in several separate clinical trials. Objectives: - To determine if FdCyd and THU can work together to control tumor growth. - To evaluate the safety and tolerability of FdCyd and THU when given together. Eligibility: - Individuals 18 years of age and older who have advanced non-small cell lung cancer, breast cancer, bladder cancer, or head and neck cancer that has progressed after receiving standard treatment or for which no effective therapy exists. Design: - The drugs are given over 28-day periods called cycles. FdCyd and THU are given through a vein for about 3 hours each day on days 1, 5 and 8, 12 of each cycle. - Clinical Center visits: FdCyd and THU will be given through a vein on days 1, 5 and 8, 12 of each cycle. During the Clinical Center visits, researchers will perform study tests and procedures to see how the study drugs are affecting the body. - Patients will undergo a number of tests and procedures during the treatment cycle, including physical examinations, blood and urine samples for standard tests, imaging studies (ultrasound, magnetic resonance imaging (MRI) or computed tomography (CT) scans) to evaluate tumor growth, and blood and urine samples to evaluate the amount of FdCyd and THU in the body and the body's response to the drugs. - Patients may continue to receive FdCyd and THU if their cancer does not grow, if they do not have too many side effects, and if they are willing to do so.

NCT ID: NCT00978081 Completed - Clinical trials for Head and Neck Cancer

Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors

Start date: January 2009
Phase: Phase 1
Study type: Interventional

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. PURPOSE: This randomized phase I trial is studying the side effects and best dose of photodynamic therapy in treating patients with premalignant or early stage head and neck tumors.

NCT ID: NCT00973947 Completed - Clinical trials for Head and Neck Cancer

Customized Headrest or Standard Headrest in Holding Patients Still While Undergoing Radiation Therapy for Head and Neck Cancer

Start date: January 2008
Phase: N/A
Study type: Interventional

RATIONALE: Using a customized headrest to hold patients in one position may help doctors plan treatment for patients with head and neck cancer. It is not yet known whether a customized headrest is more effective than a standard headrest in holding patients still during radiation therapy. PURPOSE: This randomized clinical trial is studying a customized headrest to see how well it works compared with a standard headrest in holding patients still while undergoing radiation therapy for head and neck cancer.

NCT ID: NCT00971932 Completed - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Start date: July 2009
Phase: Phase 2
Study type: Interventional

The primary objective of this trial is to assess the antitumor activity of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) in Japanese subjects.

NCT ID: NCT00971867 Completed - Clinical trials for Head and Neck Cancer

Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer

Start date: August 4, 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator, and to evaluate the frequency and the severity of observed adverse reactions in treated subjects

NCT ID: NCT00970502 Recruiting - Clinical trials for Cancer of the Larynx

Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer

Start date: February 2007
Phase: Phase 1/Phase 2
Study type: Interventional

There is no optimal treatment for patients with recurrent head and neck cancer after previous radiation. Chemotherapy alone is not curative and patients survive an average of only 6 to 10 months. Surgery is not always possible and often cannot remove every cancerous cell. On the other hand, reirradiation with chemotherapy cures approximately 25 to 30% of patients but has significant toxicity with as many as 15 to 20% suffering from life-threatening or fatal complications. Therefore, less toxic and more effective reirradiation regimens are urgently needed. There are extensive data from animal studies and preliminary human studies showing that blocking epidermal growth factor receptor (EGFR) and COX-2 enhances radiation effect and is more effective than either treatment alone. Erlotinib is a FDA approved oral inhibitor of EGFR and celecoxib is a FDA approved COX-2 inhibitor. Both have been well studied in humans and appear to have less severe toxicity than conventional chemotherapeutic agents.

NCT ID: NCT00968656 Completed - Breast Cancer Clinical Trials

Assessment of Cellular Proliferation in Tumors by Positron Emission Tomography (PET) Using [18F]ISO-1

FISO PET/CT
Start date: January 2009
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to see if Positron Emission Tomography (PET) imaging with a radioactive tracer called 18F-ISO-1 can accurately identify how quickly cancer cells are growing or dividing. A second purpose for this study is to determine, by taking pictures, what tissues and organs of the body take up 18F-ISO-1 naturally and to determine how that uptake changes over time.

NCT ID: NCT00968435 Completed - Clinical trials for Head and Neck Cancer

Bevacizumab, Cetuximab, and Cisplatin With IMRT (Intensity-Modulated Radiation Therapy) for Patients With Stage III/IV Head and Neck Squamous Cell Carcinoma

Start date: August 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effectiveness of treatment with bevacizumab + cisplatin + cetuximab + IMRT. The doctor wishes to monitor patients for 2 years after the completion of study treatment to determine if they are cancer-free during that time. They also want to evaluate the side effects that patients experience with this treatment regimen.

NCT ID: NCT00965003 Terminated - Larynx Cancer Clinical Trials

MRI Laryngeal Imaging With a Surface Coil

Start date: July 2009
Phase: Early Phase 1
Study type: Interventional

To determine if high resolution MRI can detect early invasion of cartilage by laryngeal carcinoma, and to determine if high resolution MRI may be superior to conventional MRI imaging or CT imaging to detect cartilage invasion.

NCT ID: NCT00963586 Completed - Clinical trials for Head and Neck Cancer

Quality of Life in Patients Treated for Head and Neck Cancer

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

Rationale: Due to advanced technologies in the last decade, increasingly more treatment options are available for head and neck cancer (HNC). As a consequence decision-making with regard to choosing the best available treatment option is becoming increasingly relevant. Quality of life weights (utility scores) are an important outcome measure in this decision-making process. Utility scores can be combined with life expectancy, resulting in the Quality Adjusted Life Year (QALY). If in economic evaluation the outcomes are expressed in QALYs gained, it is possible to compare the efficiency of different interventions for different indications. However, limited evidence on utility scores after treatment for HNC is available. Objective: The investigators' main objective is to examine quality of life (QoL), both utility scores and disease specific quality of life, for different treatment modalities in HNC. Secondary objectives are to examine whether QoL differs across health states, and which factors influence QoL. As extensive data are available on disease-specific quality of life, another objective is to examine whether utility scores can be derived from a commonly used disease-specific questionnaire, the EORTC QLQ-C30/QLQ-H&N35. If this would be possible, this would limit patient burden in future clinical trials. Finally, by means of measuring patients' ability to perform their work, diet and dental consequences the investigators aim to measure the impact of HNC and its treatment. Study design: The investigators' study design is a cross-sectional survey. Study population: The study population consists of patients with HNC who are treated at least six months ago for curative radiotherapy and/or surgery with or without chemotherapy. Intervention/method: Patients are asked to fill out a single set of questionnaires (once-only). The set of questionnaires consists of three validated questionnaires, concerning health state utility (EuroQol-5D), disease-specific quality of life (EORTC QLQ-C30/QLQ-H&N35) and productivity losses (PRODISQ). In addition, two questions inquiring about patients' diet and three questions considering the dental status of these patients are added to the questionnaires. To classify patients into certain health states, physicians are asked to score adverse events in patients during follow-up visits (according to the RTOG classification). Main study parameters/endpoints: The main study parameter is QoL (both disease specific quality of life and utility scores) in a certain health state. These utility scores can be used in future cost-effectiveness studies to identify the best available treatment option. Other important study parameters are the factors influencing QoL, and the relationship between utility score and disease-specific quality of life. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: As the study involves a once only set of questionnaires, the burden is only minimal. No risks are expected to be associated with participation. It is important to gain insight into QoL, patients' ability to perform their work, diet and dental consequences in long-term follow-up of HNC patients, to allow for evidence-based decision-making regarding treatment options for HNC.