|Title||A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination with ALT-803 in Patients with BCG-Unresponsive High Grade Non-Muscle Invasive Bladder Cancer (NMIBC)|
|Description||This study is a clinical trial to evaluate the safety and efficacy of the study drug ALT-803, a cytokine-based immunotherapeutic drug, for antitumor activity in the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC) that has previously been treated with BCG and has reoccurred. ALT-803 is an investigational drug, which means that it has not been approved by the United States Food and Drug Administration (FDA), but the FDA has granted permission for ALT-803 to be tested in this study. Recently, the study sponsor (Altor BioScience Corporation) was granted FDA Fast Track Designation which expedites the development and review of drugs to treat serious conditions and fill unmet medical needs.
This study will have two groups: 80 patients who have biopsy confirmed bladder carcinoma in situ (CIS), and 20 patients who have biopsy confirmed high-grade Ta or T1 bladder cancer (without CIS). As part of this clinical trial, patients will receive BCG plus the study drug ALT-803. The study will include a screening visit, 6 treatment visits, and then 8 follow up visits every 3 months (starting from the time of first treatment) for a total participation of 24 months. Patients will receive 6 doses of the treatment, one treatment per week for 6 weeks. After the initial treatment, patients will be evaluated for disease response. Patients with residual disease will be eligible to receive 6 more treatments with BCG and ALT-803 while patients with no evidence of disease will receive maintenance therapy of 3 more treatments of BCG and ALT-803. Study participants will also be observed for any adverse effects of the study medication, and any evidence of prostate cancer progression. There is limited data about the effects of ALT-803 on humans. The expected side effects of ALT-803 are similar to the drug Proleukin® (IL-2). The following side effects from ALT-803 are most likely to occur: weight gain, anemia, low blood pressure, flu-like symptoms, increased risk of infection, bruising, skin rash, weakness, headache, dizziness, vomiting, nausea, loss of appetite, and low blood electrolytes.
|Inclusion/Notes||Bladder cancer patients who have biopsy confirmed non-muscle invasive bladder cancer (NMIBC) of the high-risk transitional cell carcinoma subtype (Ta, T1 or CIS) and are unresponsive to BCG treatment. Patients must also have adequate heart, lung, liver and kidney functions.|