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Carcinoma, Renal Cell clinical trials

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NCT ID: NCT00980213 Completed - Neoplasms Clinical Trials

Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland

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

Patient receiving sunitinib according the clinician's independent decision as first-line treatment of advanced renal cell carcinoma (RCC) will be asked for informed consent. Treatment with sunitinib will start and end solely on the treating clinicians and the patients independent discretion. Consenting patients will prospectively answer standardized quality of life questionnaires (15D, EQ-5D) during the treatment. Data on health care resource utilisation will be collected prospectively (outpatient visits, hospital stays, concomitant drugs, investigations, sick-leaves, travels). In addition, after treatment failure anti-cancer drugs, hospital stays and date of death will be recorded. The health economic data during sunitinib treatment and the length of the sunitinib treatment will be compared with the corresponding previously published data collected retrospectively from patients with the same condition treated with IFN-alfa. Stepwise regression analysis will be used to explore whether patient and tumor characteristics explain potential variation in treatment duration and costs that is not explained by the treatment. Health-related quality of life (HRQoL) data will be presented as descriptive data and compared to age-standardized general population. At least four major Finnish oncology centers have consented to participate in this study. The inclusion time will be approximately 24 months, and the study time approximately 48 months. Eighty patients will be included.

NCT ID: NCT00979966 Completed - Clinical trials for Non-clear Cell Renal Cell Cancer

Study in Non-Clear Cell Renal Carcinoma (Ncc-RCC) Temsirolimus Versus Sunitinib

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

This will be a prospective, open-label, randomized multicenter phase-II study to evaluate progression free survival (PFS) in patients with locally advanced or metastatic non-clear cell renal cell cancer (ncc-RCC) receiving Temsirolimus in comparison to Sunitinib. In most clinical trials in renal cell carcinoma (RCC), clear cell RCC have been included exclusively. There are only some limited data on the efficacy of Temsirolimus or Sunitinib in ncc-RCC showing interesting response rates for both agents. However, randomized clinical trials in this specific patient population have not yet been performed. In the proposed study a comparison Temsirolimus and Sunitinib is scheduled in first line therapy of ncc-RCC.

NCT ID: NCT00979381 Completed - Clinical trials for Renal Cell Carcinoma

Study of the Immunoresponse in Patients Treated With a Tyrosine Kinase Inhibitor

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

In this study the researchers investigate the influence of the tyrosine kinase inhibitors sunitinib and sorafenib, on the normal humoral and cellular immuno response to influenza vaccination in patients with metastases of renal cell carcinoma or a GIST.

NCT ID: NCT00979329 Completed - Colorectal Cancer Clinical Trials

Study on the Influence of Sunitinib and Sorafenib on Fatigue, QoL, Depression in Patients With Metastatic RCC or GIST

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

The purpose of this study is to assess the influence of Sunitinib and Sorafenib on fatigue, quality of life and depression in patients with metastatic renal cell or colorectal cancer or GIST. In order to get more insight in the mechanism of vascular endothelial growth factor (VEGF) related fatigue and if possible to come to a resolution for this side effect.

NCT ID: NCT00971620 Completed - Clinical trials for Hereditary Leiomyomatosis and Renal Cell Cancer

Randomized Pilot Study for the Treatment of Cutaneous Leiomyomas With Botulinum Toxin

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

Cutaneous leiomyomas are benign tumors of smooth muscle origin. They can be very painful, and current treatments for the tumors and for the associated pain do not produce satisfactory results. One potential treatment for localized severe muscle pain involves injections with botulinum toxin A. This study will investigate the effectiveness, side effects, and dosage of botulinum toxin A (BOTOX) as a treatment for patients with pain associated with cutaneous leiomyomas. This study will include 18 subjects, all of whom will be 18 years of age and older, who have pain associated with cutaneous leiomyomas. For the 24-week study, patients will be randomly assigned to one of two treatment groups. Neither the study team nor the patient will know to which group patients have been assigned. Before the study begins, all participants must provide a full medical history for research and evaluation purposes, fill out pain and quality-of-life questionnaires, and undergo an ice test in which researchers will apply ice to the site of the cutaneous leiomyomas and ask participants to evaluate the level of pain before and after ice application. Both groups will be required to keep a pain diary throughout the study to record their level of pain on a daily basis, and will be asked to avoid or restrict the use of specific medications or other remedies to treat the pain. At the first visit (Week 0), one group will receive a prescribed dose of botulinum toxin A, which will be administered as an injection into the leiomyoma, and the other (control) group will receive a placebo injection of a saline solution. Patients will return 4 weeks later, at which time they will undergo a medical examination, and the ice test, and complete questionnaires to assess responses and level of pain. Patients will return in Week 12, at which time the group assignment will be revealed (un-blinded) to investigators and patients. Patients who received placebo injections will be offered the opportunity to receive injection of botulinum toxin A into their leiomyomas. All patients will undergo a medical examination, the ice test, complete questionnaires, and continue completing their daily pain diaries at home. The final visit, in Week 24, will follow the same procedure as the Week 4 visit. At the end of the study, patients may be eligible to have one or more of the painful cutaneous leiomyomas surgically removed if the researchers believe that the skin lesions can be removed with a reasonable cosmetic result.

NCT ID: NCT00944905 Completed - Clinical trials for Renal Cell Carcinoma

Study of MDX-1203 in Subjects With Advanced/Recurrent Clear Cell Renal Cell Carcinoma (ccRCC) or Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL)

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

The purpose of this study is to determine if MDX-1203 is safe for the treatment of renal cell carcinoma or non-hodgkin's lymphoma.

NCT ID: NCT00943839 Completed - Kidney Cancer Clinical Trials

Sunitinib Malate in Treating Patients With Kidney Cancer

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

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This clinical trial is studying how well sunitinib malate works in treating patients with kidney cancer.

NCT ID: NCT00930033 Completed - Clinical trials for Metastatic Renal Cell Carcinoma

Clinical Trial to Assess the Importance of Nephrectomy

CARMENA
Start date: September 9, 2009
Phase: Phase 3
Study type: Interventional

The study compare the standard treatment with nephrectomy + sunitinib to treatment with sunitinib alone without nephrectomy. This study will be the first trial on this competitive context

NCT ID: NCT00927043 Completed - Clinical trials for Carcinoma, Renal Cell

Study Evaluating Renal Cell Carcinoma Risk Factors

MICRA
Start date: May 2009
Phase: N/A
Study type: Observational

This is an epidemiological, prospective, multicenter study designed to identify the pre-treatment clinical, molecular and genetic prognostic factors associated with progression free survival in patients naïve to renal cell carcinoma (RCC) treatment.

NCT ID: NCT00923845 Completed - Clinical trials for Renal Cell Carcinoma

Low-Intensity Stem Cell Transplantation With Multiple Lymphocyte Infusions to Treat Advanced Kidney Cancer

Start date: March 1, 2008
Phase: Phase 2
Study type: Interventional

Background: Low-dose chemotherapy is easier for the body to tolerate than typical high-dose chemotherapy and involves a shorter period of complete immune suppression. Donor immune cells called lymphocytes, or T cells, fight residual tumor cells that might have remained in the recipients body after stem cell transplant, in what is called a graft-versus-tumor (GVT) effect. The immune-suppressing drug sirolimus appears to help prevent graft-versus-host disease (GVHD), a side effect of stem cell transplant in which donated T cells sometimes attack healthy tissues, damaging organs such as the liver, intestines and skin. Th2 cells are cells collected from the transplant donor and grown in a high concentration of sirolimus. Objectives: To determine whether stem cell transplantation using low-dose chemotherapy and sirolimus-generated Th2 cells can cause a remission of advanced kidney cancer. Eligibility: Patients between 18 and 75 years of age who have kidney cancer that has spread beyond the kidney and who have a tissue-matched sibling stem cell donor. Design: Patients undergo stem cell transplantation as follows: - Low-intensity chemotherapy with pentostatin and cyclophosphamide over a 21-day period to reduce the level of the immune system to prepare for the transplant. Pentostatin is given through a vein (intravenous (IV)) on days 1, 8 and 15; cyclophosphamide tablets are taken by mouth for 21 consecutive days. - Sirolimus tablets, taken by mouth, starting 2 days before the transplant and continuing until 60 days after the transplant. - IV infusions of stem cells and Th2 cells. Following the transplant, patients have the following procedures: - Additional Th2 cell infusions on days 14 and 45 after the transplant. - Follow-up visits at the National Institutes of Health (NIH) Clinical Center twice a week for the first 6 months after the transplant and then less frequently for at least 5 years to evaluate response to treatment and treatment side effects. Evaluations include a bone marrow aspirate and biopsy 1 month after transplant and periodic blood tests and imaging procedures (e.g., computed tomography (CT) or magnetic resonance imaging (MRI) scans).