View clinical trials related to Carcinoma, Renal Cell.
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Title: Radiotherapy as an immunological booster in patients with metastatic melanoma or renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic and therapeutic response Phase: Proof of Principle phase II study Study Design: Single center, open-label trial to assess the immune response and potential biomarkers predictive of response Study Duration: Total duration: 36 months Enrollment: 20 months Treatment: 5 months per patient Follow-up every three months Number of Subjects: Mini-max two-stage Simon design: • Step 1: 7 patients enrolled If tumor antigen-specific immune response is observed in at least 3 patients: • Step 2: recruitment of an additional 12 patients
The purpose of this study is to investigate the effectiveness of intravenous fosaprepitant therapy to reduce nausea and vomiting during the treatment of high dose interleukin-2 (HD IL-2) therapy for metastatic melanoma or metastatic renal cell carcinoma. Fosaprepitant is an intravenous (IV) medication that is FDA- approved for use in adults for the prevention of nausea and vomiting during chemotherapy. Fosaprepitant works by blocking the neurokinin-1 receptor, which is a receptor in the brain that is known to cause nausea and vomiting. Past studies estimate that up to 70% of patients undergoing treatment with HD IL-2 will have nausea and/or vomiting. While fosaprepitant has been used in clinical practice to treat nausea and vomiting during HD IL-2, there have not been any studies done to see how well it works. All patients will receive treatment (IV fosaprepitant) during the study during either the first or second hospital admission for HD IL-2. On the admission that the subject is not receiving IV fosaprepitant, the subject will receive placebo (a medicine that looks like fosaprepitant, but is not active). The study is double-blinded, which means neither the subject, nor the study doctor will know to which group you have been assigned to that admission (IV fosaprepitant or placebo). This study design was chosen to limit the potential for bias, which means the trial was designed to try to ensure that unknown factors do not affect trial results. When patients start the study, patients will be randomly assigned to one of two groups: those who receive treatment (IV fosaprepitant) first and those who receive placebo first. During the first admission, subjects will be given the IV fosaprepitant or IV placebo during admission. During the second admission, subjects will 'crossover' and receive the other treatment that they did not receive during the first admission. Improvement in nausea and vomiting will be assessed by counting the number of nausea and vomiting episodes, recording if the subject needs additional medication for nausea and vomiting, and by using patient questionnaires.
The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.
This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, urologic and lung cancers. Education and telephone counseling may reduce stress and improve the well-being and quality of life of caregivers of cancer patients.
To evaluate the feasibility and efficiency of zero ischemia laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional laparoscopic partial nephrectomy.
Partial nephrectomy is a widely accepted alternative to radical nephrectomy in patients with clinically localized, unilateral renal cell carcinoma and a normal contralateral kidney. Interruption of renal blood flow via pedicle clamping is often necessary during partial nephrectomy, especially for complex tumors with deep parenchymal invasion. Ischemia-reperfusion injury is a complex process involving several mechanisms including renal vasoconstriction, extensive tubular damage and glomerular injury. The investigators will examine the postoperative renal function of patients who received intraoperative ketorolac and remote ischemic preconditioning during partial nephrectomy.
This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cabozantinib-s-malate is more effective than sunitinib malate in treating patients with kidney cancer.
This research study is a PHase II clinical trial, which tests the safety and effectiveness of an investigational combination of drugs to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is being studied. It also means that the FDA has not yet approved these drugs or combination of drugs for use in participants, including people with your type of cancer. Tivozanib is an anti-angiogenesis medicine that fights cancer by cutting off a tumor's blood supply so that it does not get the blood and nutrients it needs to grow. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to slow the growth of cancer cells. Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of pancreatic cancer and several other cancers. It is not approved for the treatment of renal cell carcinoma. Previous research suggests combining gemcitabine with tivozanib may have some effectiveness in treating metastatic renal cell carcinoma. The purpose of this research study is to determine the effectiveness of tivozanib as a treatment for renal cell carcinoma. The purpose of this research study is to also determine if the combination of tivozanib and gemcitabine is effective in treating your type of cancer if your cancer becomes unresponsive or gets worse with tivozanib as treatment alone. The safety of the combination of tivozanib and gemcitabine will also wbe studied. Another goal of this research study is to learn more about how tivozanib alone and the combination of tivozanib and gemcitabine may work to treat renal cell carcinoma. During the research study we will perform blood tests to measure the level of substances in the blood such as proteins (biomarkers) that may predict who will respond to treatment with tivozanib and gemcitabine.
INVESTIGATIONAL PRODUCT: TLC388 (Lipotecan*) *Lipotecan is a drug product of TLC388 HCl. PHASE OF DEVELOPMENT: Phase II No. OF PATIENTS: Approximately 40 (Stage I: 15 evaluable patients, Stage II: 25 evaluable patients) STUDY OBJECTIVES: Primary • To evaluate non-progression disease (non-PD) rate at the end of cycle 6 Secondary - To evaluate progression free survival (PFS) - To evaluate overall survival (OS) - To evaluate the duration of non-PD - To evaluate objective response rate (ORR; where ORR= CR+PR) and duration - To evaluate the safety profile of TLC388 - To evaluate change in health-related quality of life (HRQOL) at the end of cycle 6 STUDY DESIGN: This is a Phase II, open-label, single-arm, multi-centre study to evaluate TLC388 monotherapy in patients with locally advanced and/or metastatic renal cell carcinoma (RCC).