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Renal Cancer clinical trials

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NCT ID: NCT01444456 Completed - Breast Cancer Clinical Trials

Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia

Start date: October 2011
Phase: N/A
Study type: Observational

This is a multicenter, international, prospective, observational study of patients who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to treat symptomatic anaemia. Quality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of ≥1 g/dL

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: NCT01218867 Terminated - Metastatic Cancer Clinical Trials

CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer

Start date: November 10, 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Background: The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients metastatic cancer that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patient s white blood cells with a retrovirus that has the gene for anti-vascular endothelial growth factor receptor (VEGFR2) incorporated in the retrovirus. Objectives: - To determine a safe number of these cells to infuse and to see the safety and effectiveness of cell therapy using anti-VEGFR2 gene modified tumor white blood cells to treat recurrent or relapsed cancer. Eligibility: - Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with metastatic cancer that has not responded to or has relapsed after standard treatment. Design: - Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed - Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti-VEGFR2 cells. {Leukapheresis is a common procedure which removes only the white blood cells from the patient.} - Treatment: Once their cells have grown the patients will be admitted to the hospital for the conditioning chemotherapy, the anti-VEGFR2 cells and aldesleukin. They will stay in the hospital for about4 weeks for the treatment. - Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.

NCT ID: NCT01138124 Completed - Hypertension Clinical Trials

Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD)

Start date: March 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 the Adverse Events Reporting System 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 primary objective of this study is to determine whether exposure to gabapentin is associated with an increased risk of developing pancreatic cancer or renal cancer in the United Kingdom (UK) General Practice Research Database (GPRD). Almost all members of the UK population are 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. 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. Data on gabapentin prescriptions are obtained for cases and controls from study cohort entry to the index date. Crude and adjusted odds ratios and 95% confidence intervals (CI) will be produced from conditional logistic regression models, with additional analyses evaluating for latency and dose-response. For pancreatic cancer, covariates are smoking, body mass index, diabetes, epilepsy, neuropathic pain, and chronic pancreatitis. For renal cancer, covariates are smoking, body mass index, diabetes, hypertension, diuretic use, epilepsy, and neuropathic pain.

NCT ID: NCT01109394 Recruiting - Sarcoma Clinical Trials

Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies

Start date: April 21, 2010
Phase:
Study type: Observational

Background: - Laboratory investigators who are studying common childhood cancers are interested in developing a tissue repository to collect and store blood, serum, tissue, urine, or tumors of children who have cancer or adults who have common childhood cancers. To develop this repository, additional samples will be collected from children and adults who have been diagnosed with common childhood cancers such as leukemia and tumors of the central nervous system. Objectives: - To collect and store blood, serum, tissue, urine, or tumor samples of children who have cancer or adults who have common childhood cancers. Eligibility: - Individuals who have been diagnosed with a common childhood cancer (e.g., leukemia) regardless of patient age. - Children, adolescents, and adults who have been diagnosed with a type of cancer more commonly found in adults. Design: - Extra blood, serum (the liquid part of blood), tissue, urine, or tumor samples will be collected from participants at a time when sampling is required for medical care or as part of a research study. - No additional procedures will be performed for the sole purpose of obtaining additional tumor tissue, aside from what is required for clinical care.

NCT ID: NCT01086696 Terminated - Breast Cancer Clinical Trials

A Pilot Study of F-18 Paclitaxel (FPAC) PET for Evaluating Drug Delivery of Solid Tumors in Breast, Lung, Renal, and Adrenal Cancers

Start date: March 9, 2010
Phase: Early Phase 1
Study type: Interventional

Background: - Paclitaxel is a chemotherapy drug that is commonly used to treat different types of cancers. However, cancer tumors can become resistant to paclitaxel, and as a result they will fail to accumulate sufficient concentrations of paclitaxel to kill the cancer cells. Researchers are interested in studying whether tumors have become resistant to paclitaxel, but to do so it must be possible to see how much paclitaxel is absorbed by the tumor cells. - 18F-Fluoropaclitaxel (FPAC) is a form of paclitaxel that has been modified to be slightly radioactive in order to show up on positron emission tomography (PET) scans. By injecting a very small amount (much less that that used to treat tumors) of the radiolabeled drug into the body, researchers hope to use PET scans to evaluate the amount of the drug absorbed by solid tumors. Because FPAC is best used to study tumors located above the diaphragm, all subjects in the study will have tumors near or above the diaphragm. Objectives: - To determine the safety and effectiveness of FPAC as a radiological evaluation chemical. Eligibility: - Individuals at least 18 years of age who have been diagnosed with breast, adrenal, renal, or lung cancer and have a tumor located someone in the body at least 1 centimeter above the diaphragm. Design: - Participants will be screened with a physical exam, blood tests, and imaging studies as directed by the study researchers. - Participants will receive a single dose of FPAC, followed by a series of PET scans. Regular scans will be performed for 3 hours after the dose of FPAC. - Participants will also have a single dose of a more conventional radiotracer, followed by a series of PET scans. The results of the two sets of scans will be compared with information from previous imaging studies of participants' tumors.

NCT ID: NCT01012427 Completed - Renal Cancer Clinical Trials

Percutaneous Renal Tumor Cryoablation Followed by Biopsy

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

This study is being done to test how effective cryoablation is in killing cancer cells. Cryoablation uses freezing temperatures to treat cancer. Cryoablation works by creating freezing temperatures within a needle probe. When this probe is inserted into a cancer, the freezing temperatures are used to try and kill the cancer. Unfortunately, the investigators don't know how well cryoablation works at destroying the cancer. This study will allow us to check to see how well cryoablation works for kidney cancers. After the investigators destroy the kidney cancers using cryoablation, the investigators will followup with you every 5-7 months to make sure the cryoablation worked and that the cancer was destroyed.

NCT ID: NCT01005797 Completed - Soft Tissue Sarcoma Clinical Trials

Study of Panobinostat in Combination With Sorafenib in Kidney, Soft Tissue or Lung Cancers

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

The purpose of this study is to determine if a new investigational drug called Panobinostat is safe, tolerable and to obtain an initial assessment of efficacy, when given in combination with Sorafenib for the treatment of certain types of lung cancer, kidney cancer and soft tissue sarcoma.

NCT ID: NCT00923390 Terminated - Kidney Cancer Clinical Trials

Phase 1/2 Study of Metastatic Renal Cancer Using T-Cells Transduced With a T-Cell Receptor Which Recognizes TRAIL Bound to the DR4 Receptor

Start date: March 2, 2009
Phase: Phase 1
Study type: Interventional

Background: - An experimental cancer treatment procedure involves taking a patient s own tumor or blood cells, modifying them with a gene that targets proteins on the surface of tumor cells, and growing those cells in a laboratory. The modified cells are then given back to the patient by intravenous (IV) transfusion, in the hope that the new cells will attack and destroy the cancer cells without harming healthy tissue. - This procedure has been used for melanoma patients, and researchers are now attempting to use this treatment for patients with renal (kidney) cancer. In the laboratory, this attack kills nearly all kidney cancers tested, but not normal tissues. However, the effectiveness and possible side effects of this treatment are still being studied. Objectives: - To find out if cells modified to target DR4 and TRAIL (two proteins found on the surface of many kidney tumors) are effective in treating kidney cancer. - To determine the maximum tolerated dose (the highest dose that does not cause unacceptable side effects) of the modified cells. Eligibility: - Patients 18 years of age and older with metastatic renal cancer whose disease has not responded to standard treatment. - Patients will be divided into two study branches: Arm A for those who will be receiving modified cells from their biopsied tumor, and Arm B for those who will be receiving their own modified white blood cells. Design: - Five-stage treatment process, outpatient for stages 1 and 5 and inpatient for stages 2 through 4: - Work-up (1 to 2 weeks): Physical examination, heart and lung function tests, imaging tests, blood and/or tumor samples taken. - IV chemotherapy (1 week): Cyclophosphamide and fludarabine to prepare for the new cell infusion. - IV cell infusion and treatment with IL-2 to support the modified cells (4 days). - Recovery (1 to 2 weeks): Recover from effects of chemotherapy and infusion. - Follow-up (every 1 to 6 months): Return to clinic for physical exam, review of side effects, other tests. - Follow-up evaluations will continue to determine the success of the treatment. - Evaluations during the treatment period: - Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant. - Blood and urine tests. - Disease evaluation and monitoring on both inpatient and outpatient basis. - Because researchers do not know the long-term side effects of gene therapy, patients will be asked to participate in long-term follow up for up to 15 years. The follow-up will involve yearly physical exams and medical history, and blood collection (3, 6 and 12 months after treatment, and every year after that).

NCT ID: NCT00896454 Completed - Breast Cancer Clinical Trials

Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium

Start date: November 16, 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium </= 11.5 mg/dL (2.9 millimoles /L) by day 10.