Trials to Note

Periodically, BCAN will highlight certain clinical trials that are actively recruiting patients by providing a description of that trial and its eligibility requirements. Each description is prepared by the sponsor of each trial. This service is not intended as an endorsement by BCAN of any particular trial, or of the benefits of one trial over another.

  • A study using HS-410 as Adjuvant Therapy for Patients with High-Risk, Non-Muscle Invasive Bladder Cancer: This is a phase 1/2 trial of HS-410 in patients who have completed surgery and intravesical BCG therapy. HS-410 is a therapeutic vaccine made from a human bladder cancer cell line that has been engineered to express soluble gp96, a chaperone protein that can present tumor antigens to the immune system and enhance the immune response against tumor cells. For more information please visit:
  • A clinical trial for patients with non-muscle invasive bladder cancer (CIS or CIS with Ta or T1) for whom BCG therapy has not been effective: This is a Phase 2/3 clinical trial to evaluate a 6-week intravesical installation therapy designed to achieve an immunological response. The researchers expect to begin enrolling participants in July, 2013. For more information please visit:
  • A Multi-Histology Phase II Study of 5-Fluoro-2-Deoxycytidine With Tetrahydrouridine (FdCyd + THU): Two experimental drugs, FdCyd (also called 5-fluoro-2′-deoxcytidine), and THU (also called tetrahydrouridine), are undergoing trials to test their effectiveness in treating cancer (including bladder cancer) that has not responded to standard therapies. FdCyd is thought to work by changing how genes work in cancer cells. THU does not have any anticancer effects on its own, but it helps keep the other drug,FdCyd, from being broken down by the body. For more information please visit:
  • A clinical trial for patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy treatment: This is a Phase 2 clinical trial to evaluate treating patients with OGX-427 combined with docetaxel. OGX-427 is a drug that works by inhibiting producting of heat shock protein (Hsp27) to disable cancer cells’ defenses and overcome treatment resistance. For more information please visit:
  • DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma: This is a multicenter, open-label, Phase 2 study. Subjects will be randomized to either the investigational product, DN24-02, or to standard of care. The purpose of this study is to compare the length of survival between these 2 groups of subjects. Other purposes of the study are to learn about the safety of DN24-02, to learn if it delays the time until urothelial cancer recurs, and to learn if the immune system responds to treatment with DN24-02. All subjects will be followed for this study for the remainder of their lives. For full details, click here
  • For adults with high grade BCG-refractory or relapsed non-muscle invasive bladder cancer (NMIBC): This Phase 2 study is designed to assess the efficacy and safety of INSTILADRIN (rAd-IFN with Syn3) when given intravesically to patients with high grade non-muscle invasive bladder cancer who are refractory to or have relapsed from BCG therapy. For full details, see the study listing at:
  • For adults with superficial (Ta, T1, Tis) recurrent bladder cancer refractory to standard intravesical therapy, who are eligible to receive taxane (Paclitaxel, albumin-bound) treatment.This is a Phase I & II trial at Columbia University that studies the use of an investigational drug, Abraxane (aka albumin-bound Paclitaxel), intravesically for bladder cancer that has recurred after receiving standard intravesical therapy including BCG, mitomycin, interferon or any combination thereof. Abaxane has the ability to be diluted in water and not lipid-based solutions allowing it greater access to sites in the bladder. The purpose of the trial is the study Abraxane’s safety, toxicity, and efficacy for treatment of recurrent transitional cell cancer of the urinary bladder. The Phase I trial is a dose-escalation study that will enroll up to 18 patients. All treated patients will be followed for up to 12 months. For full details, see the study listing at:
  • For adults with advanced/metastatic urothelial carcinoma that has not responded to standard treatment: This phase II study seeks to determine the safety and effectiveness of tesetaxel which is an oral chemotherapy agent. For full details, see the study listing at
  • For adults with locally advanced or metastatic urothelial cancer of the bladder, urethra, ureter or renal pelvis who are eligible to receive standard gemcitabine and cisplatin treatment or have progressive disease after cisplatin-based therapy: This is a phase Ib/II multi-center study that combines an investigational drug, ALT-801, with two approved chemotherapy drugs called cisplatin and gemcitabine. Cisplatin and gemcitabine treatment is standard of care for patients with locally advanced or metastatic bladder cancer. The ALT-801-based therapy has demonstrated anti-cancer activities against metastatic malignancies in other in-human clinical studies by enhancing the immune system. The purpose of this study is to evaluate the safety, tolerability and clinical benefit of the combined therapy with ALT-801, cisplatin and gemcitabine for bladder cancer. All treated patients will be followed for up to 36 months. For full details, see the study listing at

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