Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors
Bladder CancerThis study compare the efficacy of conventional photodynamic (PDD) guided transurethral bladder tumor resection in the operating theatre with outpatient PDD guided laser destruction of bladder tumors through flexible cystoscopes.
MK-3475/BCG in High Risk Superficial Bladder Cancer
Bladder CancerThis is a single center Phase I safety and efficacy study of MK-3475 therapy used in combination with bladder infused BCG treatment for patients, 18 years or older, with high risk superficial bladder cancer (cancer not yet involving the muscle of the bladder wall) who have had removal of their bladder tumor. Patients will be enrolled to a single treatment group of a fixed dose of MK 3475 and BCG.
The Efficacy of Neoadjuvant Atezolizumab Treatment in Patients With Advanced Urothelial Bladder...
Urothelial CarcinomaRecently, promising evidences that blocking PD-1 and PD-L1 is an efficacious way to treat advanced stage bladder cancer patients. Atezolimumab is the first PD-L1 inhibitor approved by US FDA for advanced UBC in June 2014. These novel agents will become the standard therapy for unhopeful UBC patients who fail to respond to cisplatin-based chemotherapy and finally, the first-line treatment would be changed from cisplatin-based chemotherapy to immune check point inhibitors for advanced UBC, particularly neoadjuvant setting. Additionally, along with enormous analysis of genomic landscape of bladder cancer, a consensus was reached regarding the existence of a group of Basal-Squamous-like tumors - designated BASQ - characterized the high expression of KRT5/6 and KRT14 and low/undetectable expression of FOXA1 and GATA3. This novel molecular classification can improve the identification of optimal patient population for different treatment modalities. Specifically, luminal type and basal type may have different treatment response and prognosis after initial definitive treatment, such as neoadjuvant treatments. However, there is no evidence for this topic, particularly the clinical efficacy of neoadjuvant PD-L1 inhibitors according to the BASQ classification in patients with advanced urothelial bladder cancer.
Evaluation of Naloxegol in the Prevention of POI After Cystectomy
Bladder CancerCystostomy; ComplicationsPostoperative ileus (POI) is defined as a transient reduction of bowel motility that prevents effective transit of bowel content and tolerance of oral intake following surgical interventions, especially after radical cystectomy. It remains a major factor associated with postoperative morbidity, length of hospital stay and medical costs. In order to optimize perioperative care for patients undergoing radical cystectomy in a context of an ERAS (Enhanced Recovery After Surgery) program, we will evaluate the effectiveness of systemic pharmacologic opioid antagonist treatment.
Preventing Catheter Related Bladder Discomfort (CRBD) With Bilateral Pudendal Nerve Block
Bladder NeoplasmProstatic NeoplasmsBladder irrigation with a 3 way foley catheter is an important component of post operative management of transurethral bladder surgeries. But it is associated with a high incidence of bladder discomfort. Catheter related bladder discomfort (CRBD) doesn't respond to the orthodox opioid pain medication and is greatly distressful to the patients postoperatively, adversely affecting the quality of recovery often requiring administration of additional pain medication thereby increasing treatment costs, patient dissatisfaction and longer hospital stays. Several systemic agents have been used to reduce CRBD, but they have many side effects. A trial has been planned to find a way of reducing CRBD avoid distressing systemic side effects
Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder...
Urinary Bladder NeoplasmEn bloc resection of bladder tumors (ERBT) may improve staging quality and perioperative morbidity and influence tumour recurrence
A Prospective Registry to Assess the Effectiveness and Local Tolerability of Intravesical Valrubicin...
Bladder CancerCISThe purpose of this study is to observe and describe the effectiveness and local tolerability of intravesical treatment with valrubicin for non-muscle invasive bladder cancer (NMIBC) in a cohort of subjects treated under routine practice conditions.
Activity Study of Sunitinib In Metastatic Pretreated Urothelial Cancer
Urinary Bladder NeoplasmsGemcitabine and cisplatin represent the standard first-line chemotherapy in metastatic bladder carcinoma. This regimen has replaced in most centers the MVAC combination showing a similar efficacy but less toxicity. Almost all responding patients relapse within the first year, with a median survival of 12 months. Prognosis is very poor in patients who display progressive disease after receiving combination cisplatin-based chemotherapy. No standard has yet been established for second-line treatment and well designed trials of second-line chemotherapy for metastatic transitional carcinoma of the urothelium should be given high priority. Several drugs have been used in second line for metastatic disease with poor results. The investigators have planned a Phase II study, open-label, single arm design to evaluate the activity and safety of sunitinib in metastatic urothelial carcinoma, pretreated with standard regimen (cisplatin-gemcitabine). No previous studies have been published with sunitinib in metastatic bladder cancer.
Phase I & II Trial of Intravesicular Abraxane for Treatment-refractory Bladder Cancer
Bladder CancerThe intravesical treatment of bladder cancer with Abraxane is more desirable than other taxanes due to its ability to be diluted in water and not lipid-based solutions allowing it greater access to sites in the bladder. Thus, we are interested in investigating Abraxane's safety, toxicity, and efficacy profile for the treatment of recurrent transitional cell cancer of the urinary bladder in a combined phase I & II trial. The phase I trial is designed as a dose-escalation study with cohorts of threes that will enroll a maximum of 18 patients. Dose increases will occur in groups of three patients, with each successive group receiving an increased concentration of Abraxane intravesically. No dose increase will occur until each member of the previous cohort has undergone the first instillation of the medication without experiencing a dose-limiting toxicity (DLT). Any patient who experiences a DLT will be removed from the trial and treated appropriately. If one patient in the cohort experiences a DLT an additional three patients will be enrolled and treated at that dose-level. If none of the additional three patients experience a DLT, the next group of patients will be started on the next higher dose level. If at any dose level, two or more patients experience a DLT the previous dose level will be considered as the maximum tolerated dose (MTD). An additional three patients (for a total of six patients) will then be treated at the MTD. If less than two patients experience a DLT this dose level will be established as the MTD. The phase II aspect is designed in a Simon II stage format in which to satisfy our study powering, the first stage there will be 10 patients enrolled. If there are 2 or more successful treatments in that group (negative urine cytology and bladder biopsy after 6 months), then the first stage will pass the rejection rule, and up to another 19 patients will be enrolled. If at any point in the study, there have been a total of 6 or more successes, then the phase II aspect will be considered a successful trial and the study will be completed at that point.
Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer
Bladder CancerRATIONALE: Minimal-access surgery uses a smaller opening in the body to remove the tumor than is used in standard surgery. It is not yet known whether minimal-access surgery to remove the bladder is more effective than standard surgery to remove the bladder in treating patients with bladder cancer. PURPOSE: This randomized phase II trial is studying standard surgery to see how well it works compared with minimal-access surgery in treating patients with bladder cancer.