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Carcinoma, Renal Cell clinical trials

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NCT ID: NCT01265810 Completed - Clinical trials for Hepatocellular Carcinoma

Caphosol in Oral Mucositis Due to Targeted Therapy

COMTT
Start date: November 2011
Phase: Phase 3
Study type: Interventional

Targeted therapies such as multi-targeted tyrosine kinase inhibitors (TKI) and mammalian target of rapamycin inhibitors (mTORI) in renal cell carcinoma (RCC), demonstrate a high level of efficacy with acceptable tolerability. Currently, there are five approved targeted therapies available for RCC: sunitinib (Sutent®), sorafenib (Nexavar®), pazopanib (Votrient®), temsirolimus (Torisel®), and everolimus (Afinitor®). Hepatocellular carcinoma treated with sorafenib and gastro intestinal stromal tumors patients treated with sunitinib will be included, too. Since this agents have dermatological adverse events in common, with oral mucositis (OM), hand-foot skin reaction (HFSR) and papulopustular eruption (PPE) as an disabling side effect, we require evidence based management options to prevent and treat these adverse events. The incidence of OM of any grade is for sunitinib 38%, sorafenib 28%, pazopanib 4%, temsirolimus 41%, and everolimus 44%. Recent data suggest that TKI and mTORI associated OM is distinct from conventional mucositis and more closely resembles aphthous OM. Recently, supersaturated calcium-phosphate rinse (Caphosol®), a Ca2+/PO43- mouth rinse, became available to prevent or treat OM. The objective is to assess the relieving effect of Caphosol® oral rinse on clinical outcomes which include oral intake, swallowing function and pain associated with incidence of grade ≥ 1 oral side effects and the anticancer therapy cessation in patients treated with selected targeted anticancer therapy. Patients with OM > grade 0 on targeted therapy will be randomly allocated to receive either Caphosol® or NaCl 0.9% rinse for two weeks. After the first rinse period all patients will switch to the opposite treatment arm (NaCl 0.9% or Caphosol®) for another two weeks. Duration of oral side effects, severity, pain, dose of analgesics and tolerability will be assessed weekly with the Modified-VHNSS-version-2.0 oral-specific questionnaire. Patients will be stratified by targeted anticancer agent and per tumor type (pre-defined cohorts). Objective severity of oral side effects will be assessed using the NCI-CTCAE v4.0. Correlation of subjective Modified-VHNSS-version-2.0 scores with the objective NCI-CTCAE grade, sex, age, targeted therapy type, and cancer type will be conducted.

NCT ID: NCT01265368 Completed - Clinical trials for Stage IV Renal Cell Cancer

A Clinical Study to Assess Safety and Efficacy of a Tumor Vaccine in Patients With Advanced Renal Cell Carcinoma (ASET)

ASET
Start date: November 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, proof-of-principle clinical study to assess safety and efficacy of a intradermally administered tumor vaccine (MGN1601). The study will be conducted in patients with advanced renal cell carcinoma.

NCT ID: NCT01263769 Completed - Kidney Cancer Clinical Trials

Neoadjuvant Axitinib in Locally Advanced Renal Cell Carcinoma (RCC)

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

The goal of this clinical research study is to learn if axitinib can help to control kidney cancer. The safety of this drug will also be studied.

NCT ID: NCT01258348 Completed - Clinical trials for Metastatic Renal Cell Cancer

A Phase 1b Trial in Patients With Renal Cell Cancer

Start date: July 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine a safe dose of LY573636-sodium to be given in combination with sunitinib to patients with metastatic Renal Cell Carcinoma (RCC) and to determine any side effects that may be associated with LY573636-sodium and sunitinib combination in this patient population. The tumor response rate will also be assessed.

NCT ID: NCT01254838 Completed - Clinical trials for Renal Cell Carcinoma

Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma

Start date: November 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and CTL reaction of novel peptide vaccination for advanced renal cell carcinoma

NCT ID: NCT01246843 Completed - GIST Clinical Trials

Evaluation of Cognitive Function of Patients With Sunitinib or Sorafenib

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

Patients with advanced kidney cancer or GIST (Gastro Intestinal Stromal Tumor: this is a tumor of the intestines) may be eligible for treatment with one of the following drugs: sunitinib (Sutent ®) or sorafenib (Nexavar ®). These drugs inhibit blood vessel formation in cancer cells. These cancer cells are hampered in their growth. To enlarge the investigators knowledge on the effects and side effects of these two medicines, in the University Medical Center St. Radboud lot of research is done. This study is a part of that. Patients receiving sunitinib or sorafenib tell sometimes that they feel that they are less able to concentrate, that their memory is not working properly or that they are less able to imagine a solution to a complex problem . Perhaps you recognize these symptoms as well. In how many of the patients this occurs, how severe the symptoms are and how it is caused, is still unknown. The goal of this research is to examine how memory, concentration and knowledge processing works in patients using sorafenib or sunitinib. With the research the investigators hope to get answers to the following questions: 1. How common are problems with memory, concentration and processing of knowledge in patients receiving the drug sunitinib or sorafenib? 2. What are the problems of memory, concentration and processing of knowledge in the use of sunitinib or sorafenib? 3. What could be the cause of the problems that patients experience from memory, concentration and processing of knowledge in the use of sunitinib or sorafenib? 4. Is there a link between problems with memory, concentration and processing of knowledge and also experiences of fatigue or mood of a patient?

NCT ID: NCT01243359 Completed - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

Sunitinib Malate and Bevacizumab in Treating Patients With Kidney Cancer or Advanced Solid Malignancies

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

This phase I trial studies the side effects and the best dose of sunitinib malate when given together with bevacizumab in treating patients with kidney cancer or advanced solid malignancies. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving sunitinib malate together with bevacizumab may kill more tumor cells.

NCT ID: NCT01236053 Completed - Breast Cancer Clinical Trials

Cancer in Patients With Gabapentin (GPRD)

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

High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by spontaneous reports in AERS or in the published literature. In a published case-control screening study of the association of gabapentin with 55 cancers, the only cancer that met the screening criteria for possibly increased cancer risk with gabapentin exposure was renal (including renal pelvis) cancer. This association was judged to be likely due to or substantially accentuated by confounding by cigarette smoking, hypertension, and lifestyle (Cancer Causes Control 2009;20:1821-1835). The relationship between gabapentin exposure and pancreatic cancer and renal cancer is studied in NCT01138124, and supplemental analyses for these cancers are performed in the current study. The FDA recommended GSK also study the relationship between gabapentin and all-cancer sites, as well as cancer at the following specific sites: 1) stomach, 2) anus, anal canal, and anorectum, 3) lung and bronchus, 4) bones and joints, 5) breast, 6) penis, 7) urinary bladder, and 8) other nervous system. The primary objective of this study is to determine whether exposure to gabapentin is associated with an increased risk of developing all-cancer, and these specific cancers in the United Kingdom (UK) General Practice Research Database (GPRD). Each member of the UK population is registered with a General Practice, which centralizes the medical information not only from the general practitioners themselves but also from specialist referrals and hospital attendances. Over 487 General Practices contribute data to the GPRD. The study cohort from which cases and controls are drawn is all subjects in the GPRD 1993-2008. Gabapentin was approved in the UK in May 1993. Entry into the study cohort begins Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of registration if later than Jan 1, 1993. Subjects are excluded from the GPRD cohort if they have a cancer diagnosis or a history of cancer prior to the cohort entry date. Patients with a first diagnosis of the respective cancer 1995-2008 are risk set matched with up to 10 controls within the same General Practice for age at cohort entry (within two years), sex, and year of entry into the study cohort (within one year). For cases, the index date is the date of first diagnosis of the respective cancer. The index date for controls is set as the date at which the follow-up time from cohort entry is the same as the case. The index date is chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Cases and controls will be required to have at least 2 years of follow-up in the study cohort before their index date. Cases must have no history of any other cancer diagnosis prior to the index date. Controls are required to be free of cancer diagnosis in the database up to the control's index date. Data on gabapentin prescriptions are obtained for cases and controls from study cohort entry to the index date. Gabapentin exposure will be assessed as ever/never, number of prescriptions, cumulative dose, and cumulative duration, with a 2 year lag period incorporated to control for protopathic bias (gabapentin prescription for initial pain symptoms of undiagnosed cancer) and latency (time between cancer onset and specific GPRD cancer diagnosis). Crude and adjusted odds ratios and 95% confidence intervals (CI) will be produced from conditional logistic regression models, with additional analyses evaluating for dose-response. Covariates include indications for gabapentin use and risk factors for each cancer.

NCT ID: NCT01235962 Completed - Cancer Clinical Trials

A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC)

PROTECT
Start date: November 30, 2010
Phase: Phase 3
Study type: Interventional

This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery.

NCT ID: NCT01227213 Completed - Hypertension Clinical Trials

The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma

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

Rationale: The introduction of angiogenesis inhibitors, like sunitinib and bevacizumab, has improved the outcome of patients with several types of cancer remarkably. However, their application is hampered by side effects, such as development of hypertension with consequences for renal and cardiac function. Moreover patients treated with angiogenesis inhibitors may suffer from weight loss, and insulin sensitivity during treatment appears to change. The treatment with angiogenesis inhibitors, will improve life expectancy of patients with various cancer diagnoses and therefore the clinical relevance of both short term and long lasting adverse events will translate into reduced quality of life. In addition, premature withdrawal of angiogenesis inhibitors due to side effects may result in lower response, shorter duration of response and possibly a shorter survival. Therefore, adequate treatment of above mentioned side effects in patients treated with angiogenesis inhibitors is of relevance for the response rate, the duration of progression free survival and overall survival and for quality of life. Mechanistic insight in the pathogenesis of these side effects will help optimizing treatment. Objective: The primary objective of the study is to investigate the effect of sunitinib on endothelial function, insulin sensitivity, renal function and renal blood flow. Study design: Single-centre non randomized observational study Study population: 30 Patients (>18 years old) starting with sunitinib as treatment for metastatic renal cell carcinoma.