CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON)
Non-muscle Invasive Bladder CancerThe study consisted of 2 sequential parts. Part A assessed the safety and tolerability of CAVATAK administered via intravesical instillation in patients with non-muscle invasive bladder cancer scheduled to undergo TUR. Part B assessed the safety and tolerability of CAVATAK administered in sequential combination with low dose Mitomycin C in the same patient population.
VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer
Bladder CancerThis phase I/II trial will assess the safety and efficacy of intravesical instillation of VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after TURB (transurethral resection of the bladder) and standard BCG therapy. In phase I part of the trial, a 3+3 dose de-escalation design will be applied to determine the recommended phase II dose (RP2D). In phase II part of the trial, a maximum of 39 patients will be treated at RP2D to further assess the preliminary efficacy of VPM1002BC.The efficacy and tolerability of VPM1002BC will be compared to results previously reported for BCG in a similar population. The quality of life will be also investigated as a secondary endpoint. Additional immunology assessments are foreseen as exploratory analyses to investigate the immunogenicity of VPM1002BC. The Phase II of the trial has been opened on 27.07.2016.
Irreversible Electroporation(IRE) For Unresectable Urinary Bladder Neoplasms
Urinary Bladder NeoplasmsThe purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Urinary Bladder Neoplasms.
Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer
Locally Advanced Bladder CancerRadical Cystectomy is still the standard treatment in muscle-invasive Bladder cancer. Local recurrence is still the major cause of failure together with distant metastasis. postoperative radiotherapy succeeded to decrease the local recurrence and hence improved the overall survival. Adjuvant chemotherapy has also improved the survival in different studies. This study is performed to test the efficacy and toxicity of adding the two modalities together compared to each modality alone.
Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer
Carcinoma in SituNon Muscle Invasive Bladder CancerThis is a Phase II pilot study to explore the effect of intravesical TMX-101 in patients with CIS bladder cancer, as assessed by histology and cytology after TMX-101 treatment.
Adaptive Radiotherapy Using Plan Selection for Bladder Cancer
Adverse Effects for Adaptive RT of Bladder CancerThis protocol describes a Phase 2 clinical trial of online adaptive Radiotherapy, using a library of 3 dose plans corresponding to Small, Medium and Large size bladder. The procedure includes 'Common Toxicity Criteria for Adverse Effects'(CTCAE) for registration of adverse effects (baseline, every 2'nd week during RT, 2 weeks, 3, 6, 12 and 24 month after RT) as well as cineMR for intra-fractional motion (baseline and every week during RT). Patients receive standard non-adaptive RT in the first week. Delineations of the bladder on the Cone-Beam scans (CBCT) from first week of treatment are used for planning the Small and Medium size bladder plans. Large size plan are the standard non-adaptive treatment plan used for the first week of treatment. A margin of 5 mm for intra fractional movement is used.
Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer
Bladder CancerCarcinoma4 moreThe main purpose of this study is to find out the dose of enzalutamide that can be safely given with gemcitabine and cisplatin in patients with advanced bladder cancer. Researchers also want to find out the side effects of these drugs when given together. This study will also help in finding out the effect on tumor of the combination of enzalutamide, gemcitabine and cisplatin.
Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer
Non Muscle Invasive Bladder CancerThe treatment of non-muscle invasive bladder cancer (NMIBC) is problematic given the variable natural history of the disease. Although contemporary treatment options are limited, new targets and new approaches are under investigation for preventing bladder cancer recurrence and progression. Among those, COX-2 is a promising target since plays an important role in urothelial carcinogenesis and iCOX-2 selective inhibitors, like celecoxib, effectively inhibit tumor development and growth and enhances survival, in bladder cancer in vitro and in vivo models. Therefore, the investigators conducted a pilot study of celecoxib to prevent recurrence in patients with intermediate risk NMIBC.
Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer
Non-muscle Invasive Bladder Cancer (NMIBC)Purpose of this study is to determine appropriate dosing of ABI-009 and evaluate the safety and anti-tumor activity of ABI-009 in treatment of non-muscle invasive bladder cancer
Sirolimus, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Bladder Cancer
Recurrent Bladder CarcinomaStage II Bladder Cancer2 moreThis phase I/II trial studies the side effects and best dose of sirolimus when given together with cisplatin and gemcitabine hydrochloride and to see how well they work in treating patients with bladder cancer. Biological therapies, such as sirolimus, may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving sirolimus together with cisplatin and gemcitabine hydrochloride may be an effective treatment for bladder cancer.