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Kidney Neoplasms clinical trials

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NCT ID: NCT01715935 Completed - Clinical trials for Clear-cell Metastatic Renal Cell Carcinoma

Biomarkers Before and After Nephrectomy of Locally Advanced or Metastatic Renal Cell Carcinoma Treated With Everolimus

NEORAD
Start date: June 2012
Phase: Phase 2
Study type: Interventional

Disease and Stage: Metastatic and locally advanced clear cell renal carcinoma An open-label, exploratory, single-arm, multicenter trial. Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest period prior to nephrectomy. Two to four weeks after surgery, everolimus will be reintroduced only for metastatic patients until disease progression, unacceptable toxicity, withdrawal of patient consent, or other stopping rules are met.

NCT ID: NCT01714765 Completed - Clinical trials for Metastatic Clear Cell Renal Cancer

Dose Escalation Study Investigating Everolimus and Dovitinib in Metastatic Clear Cell Renal Cancer

DEVELOP
Start date: April 2011
Phase: Phase 1
Study type: Interventional

When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This is very difficult to treat and almost all patients will die of their disease within 3 years. Sunitinib has become standard therapy for untreated patients with metastatic clear cell renal (kidney) cancer. It targets a growth factor known as VEGF which is important in treating renal cancer. Although the results with this drug are impressive, patients develop resistance to the drug, relapse and die of renal cancer. It is currently standard practice is to treat patients with everolimus when resistance to sunitinib occurs; this is associated with clear clinical benefit. However the median time to progression with everolimus is 4.9 months in previously treated patients, therefore further improvement in treating patients is required. The optimal way of achieving this is to increase the efficacy of everolimus by adding agents which directly target the cause of resistance to sunitinib. Dovitinib is a promising new drug in renal cancer. Dovitinib blocks cellular functions such as activation of downstream signalling molecules, cell proliferation and survival. Combining dovitinib and everolimus is very attractive. This trial is aimed to establish the maximum tolerated dose for the combination of dovitinib and everolimus in clear call renal cancer, which can then be taken into a randomised phase II study. A maximum of 30 patients will be recruited into this multi centre national trial. Expansion Cohort: The study has established the MAD and the MTD. The MTD was Cohort 0 (Everolimus 5mg and Dovitinib 200mg). 6 patients were recruited in this cohort with only 1 patient experiencing a DLT. A further 3 patients were recruited into Cohort 1 (Everolimus 5mg and Dovitinib 300mg), where 2 patients experienced a DLT. A total of 7 assessable patients will be recruited during the expansion phase at the MTD (Cohort 0: Everolimus 5mg and Dovitinib 200mg) to further define the safety, tolerability, efficacy, PK and biological end points. Assessable patients for the expansion cohort are defined as being on the study for a minimum of 6 weeks. Any patients enrolled who are not assessable will be replaced.

NCT ID: NCT01688999 Completed - Clinical trials for Urothelial Carcinoma

Cabozantinib for Advanced Urothelial Cancer

Start date: September 11, 2012
Phase: Phase 2
Study type: Interventional

Background: - Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is approved for medullary thyroid cancer. However, studies have shown that prostate and ovarian tumors respond to it. Researchers want see if cabozantinib can be a safe and effective treatment for urothelial cancer. Objectives: - To test the safety and effectiveness of cabozantinib for advanced urothelial cancer. Eligibility: - Individuals at least 18 years of age who have advanced urothelial cancer that has not responded to standard treatments. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor tissue samples will also be collected. Imaging studies will also be performed. - Participants will take cabozantinib by mouth once per day on each day of a 28-day cycle. - Treatment will be monitored with frequent blood tests and imaging studies. - Participants will continue to take the study drug for as long as their cancer does not worsen and side effects are not too severe.

NCT ID: NCT01676428 Completed - Cancer Clinical Trials

A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases

FASTRACK
Start date: May 2012
Phase: N/A
Study type: Interventional

This is a "proof of concept" study, to assess the feasibility of introducing a novel high-precision radiotherapy technique called "stereotactic radiosurgery" (SRS) or "stereotactic body radiotherapy" (SBRT) for the treatment of kidney cancers in Australia. This study aims to invite 20 patients with renal cell carcinoma and 10 patients with isolated adrenal metastases from non-small cell carcinoma who are either medically inoperable, high risk for surgery, or decline surgery to participate. In cohort of patients with renal cell carcinoma, both patients with primary disease only, and those patients who have limited metastases (≤5) will be eligible. Besides technical feasibility of delivering this treatment, this study will be to assess efficacy, toxicity and tumour response using a novel imaging biomarker called diffusion weighted-MRI.

NCT ID: NCT01614808 Completed - Clinical trials for Recurrent Wilms Tumor and Other Childhood Kidney Tumors

Studying Biomarkers in Urine Samples From Younger Patients With Wilms Tumor

Start date: June 2012
Phase: N/A
Study type: Observational

This research study is looking at biomarkers in urine samples from patients with Wilms tumor. Studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment

NCT ID: NCT01608165 Completed - Renal Cancer Clinical Trials

A Feasibility Study for a Multicentre Randomised Controlled Trial to Compare Surgery With Needle Ablation Techniques in People With Small Renal Masses (4cm)

CONSERVE
Start date: June 2012
Phase: N/A
Study type: Interventional

The number of people diagnosed with kidney cancer has doubled over the past 20 years, making it the eight most common cancer in the UK. Most tumours are less than 4cm in size, but over 80% of these are malignant (cancerous) and if left untreated, will slowly grow and spread. Current standard treatment for these small kidney cancers is to remove the diseased part of the kidney in an operation called a partial nephrectomy, but this can be quite a difficult operation. Because of the small tumour size and difficulties with the operation, other treatments have been developed to destroy the tumours. These treatments include radiofrequency ablation, which means that the tumour is destroyed by heat, and cryoablation, which means that the tumour is frozen and destroyed. Although removing the part of the diseased kidney in an operation is the tried and tested way to treat the kidney cancer, it does have risks and complications, such as bleeding. The other two treatments are less intrusive to the patient, and are less complicated as they do not require such a large operation as having part of the kidney removed, but it is not known if they are as good at destroying all of the tumour, and whether or not patients who have their tumour destroyed with these new methods require further treatment in future. In this study, the investigators are trying to determine if a large-scale study comparing these treatments is possible which is why this is called a feasibility study. The investigators are also looking at whether patients would be willing to be randomly assigned to a treatment group. The results of this study will then be compared to see how effective each of the treatments were and whether the number of patients who were happy to be randomly assigned to a treatment could be used to determine the number of patients required in a large-scale trial.

NCT ID: NCT01606787 Completed - Renal Cancer Clinical Trials

Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes

Start date: May 22, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if a medication called mannitol, can help the kidney maintain its function after kidney surgery. Mannitol is used to cause an increase in urine production (it is a diuretic). For many years, mannitol has been given to patients in the hope it would improve the kidney's circulation, and in doing so reduce the impact of the surgery on the kidney. Mannitol is given during the surgery before the blood supply to the kidney is stopped. The blood supply to the kidney is stopped in order to minimize any blood loss during the removal of the tumor, and also to assist the surgeons view of the kidney anatomy. Once the tumor is removed the blood supply to the kidney is resumed. Sometimes a side effect of this temporary reduction in blood supply to the kidney is the loss of some kidney function. This may happen either in the short term (right away) or long term (months or years later). In studies done on animals, mannitol was able to lessen this damage to kidney function. However, no human study has ever confirmed that mannitol has the same helpful effect in humans. There is some suggestion that it may have no effect. Because sufficient research has yet to be done on humans, many surgeons do not give mannitol. A recent study, conducted at Memorial Sloan Kettering which looked back at patients who had undergone partial nephrectomies, an operation where only the portion of the kidney that contains the tumor is removed and enables the normal, unaffected portion of the kidney to be preserved. The results of this study demonstrated no significant difference in kidney function when the investigators compared patients who were given mannitol to those who were not. The investigators hope that this study will help clarify the effectiveness or not of mannitol on kidney function. During the surgery to remove the kidney tumor, patients will receive either mannitol or a placebo. A placebo, is a harmless medication that has no effects. The impact of mannitol compared to the placebo will be assessed by routine blood tests and imaging (kidney scan) 6 months after your surgery.

NCT ID: NCT01586104 Completed - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases

Start date: February 2011
Phase: N/A
Study type: Interventional

This pilot clinical trial studies intensity-modulated radiation therapy (IMRT) in treating younger patients with lung metastases. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

NCT ID: NCT01576198 Completed - Kidney Cancer Clinical Trials

Studying Biomarkers in Samples From Younger Patients With Wilms Tumor

Start date: April 2012
Phase: N/A
Study type: Observational

RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors to learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.

NCT ID: NCT01571401 Completed - Clinical trials for Supervised Physical Activity Plus Exercise Counseling

Trying Activity in Kidney Cancer Survivors (TRACKS) Trial

TRACKS
Start date: April 2012
Phase: Phase 2
Study type: Interventional

Objectives: The purpose of this study is to find out if a new program can help kidney cancer survivors (KCS) increase their physical activity (PA) and improve their quality of life (QoL). Methods: Fifty KCS will be recruited from a previous study using the Alberta Cancer Registry. Participants will undergo submaximal exercise testing, a physical function test and measures of height and weight, which will be completed at baseline and the end of the physical activity program (at 12 weeks). Participants will also complete questionnaires on PA and QoL at the baseline, after the supervised portion of the program (at 4 weeks), and at the end of the entire program (at 12 weeks). Following baseline assessments, participants will be randomly assigned to either: (1) supervised physical activity plus traditional exercise counseling or (2) supervised physical activity plus behavioural counseling. Participants will be asked to attend six individual supervised exercise and counseling sessions over a 4-week period with a PA specialist that eventually tapers to a home-based program by the end of the program. Implications: The investigators hope that this PA intervention for KCS is feasible and results in meaningful improvements in health outcomes that can be translated to public health practice.