A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT
Bladder CancerPhase I/II study: Phase 1 is an open-label, safety study, patients who previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose intradermal (1*10^6 cells) HS-410 monotherapy. Phase 2, patients will be randomized to one of three blinded (physician-patient), placebo-controlled groups and receive either intradermal placebo or low dose (1*10^6 cells) or high dose (1*10^7 cells) vesigenurtacel-L in combination with induction and maintenance intravesical BCG. Patients who do not receive BCG will be enrolled into an open-label, non-randomized group receiving high dose (1*10^7 cells) intradermal HS-410 monotherapy.
Chemoradiation for Bladder Preservation After Complete Response to Neoadjuvant Chemotherapy
Bladder CancerBladder Carcinoma2 moreBladder preservation in patients with complete response after neoadjuvant chemotherapy will lead to equivalent or superior relapse free rates compared to cystectomy rates from historical controls.
Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive...
Distal Urethral CancerProximal Urethral Cancer4 moreThe purpose of this research study is to find out what effects, good and/or bad, dose-dense (every 14 days) chemotherapy with gemcitabine (gemcitabine hydrochloride) and cisplatin given before surgery have on patients and their muscle invasive bladder cancer.
Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder...
Bladder CancerThis is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double Blind Phase qualification, patients with confirmed eligibility will be randomized to receive either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo cystoscopic and safety assessments every 3 months for 24 months from randomization. Patients with histologic evidence of recurrent disease during the study will be treated according to current treatment guidelines or local standard of care. Safety and efficacy assessments will be performed at 3 month intervals for all randomized patients throughout the study. Patients who receive single dose of apaziquone immediately following TURBT and are not eligible for randomization will be followed for 3 months by cystoscopic exam and safety assessments.
Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery...
Recurrent Bladder CancerStage 0 Bladder Cancer3 moreRationale: Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers. Purpose: This pilot study is studying the side effects of broccoli sprout extract in treating patients with transitional cell bladder cancer undergoing surgery.
Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing...
Bladder CancerHemostasisEvaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device.
PURO Panitumumab in Combination With Gemcitabine/Cisplatin in Advanced Urothelial Cancer
Urinary Bladder CancerThe primary objective of the study is to assess the efficacy of the combination consisting of gemcitabine/cisplatin and panitumumab in patients with urothelial carcinoma and wild-type HRAS (non-mutated status). The progression-free survival rate at 12 months will be compared to expectations derived from historical data, which are verified by a randomised control group without the antibody.
Trial to Evaluate Paclitaxel Plus RAD001 in Urothelial Carcinoma
Bladder CancerThis is a single arm open- label phase II- trial evaluating safety and efficacy of paclitaxel and RAD001 in patients with metastatic urothelial bladder cancer who failed prior platin-based systemic therapy.
BCG With or Without Gefitinib in Treating Patients With High-Risk Bladder Cancer
Bladder CancerRATIONALE: Biological therapies, such as BCG, may stimulate the immune system in different ways and stop tumor cells from growing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving BCG together with gefitinib may kill more tumor cells. It is not yet known whether BCG is more effective with or without gefitinib in treating bladder cancer. PURPOSE: This randomized phase III trial is studying BCG and gefitinib to see how well they work compared to BCG alone in treating patients with high-risk bladder cancer.
Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy...
Urinary Bladder DiseasesUrinary Bladder Neoplasms6 moreThe study is designed to compare the efficacy and safety of 2 treatment types for the prevention of tumor recurrence of superficial bladder cancer: A combination of bladder wall heating and local chemotherapy (Synergo) Bacillus Calmette-Guérin (BCG)