Ongoing Clinical Trials for Bladder Cancer Stage 0 With Cancer In Situ
There is currently 1 ongoing clinical trial for patients with bladder cancer stage 0 with cancer in situ. This trial is testing a new treatment called TARA-002, which is administered directly into the bladder. The study is taking place in Romania and Spain, and it focuses on evaluating the safety and effectiveness of this investigational therapy for high-grade non-muscle invasive bladder cancer.
Clinical trial locations
- Romania
- Spain
Study on the Safety and Effectiveness of TARA-002 for Adults with High-Grade Non-Muscle Invasive Bladder Cancer
This clinical trial is studying a new treatment approach for a specific type of bladder cancer called high-grade non-muscle invasive bladder cancer. The treatment being tested, TARA-002, is made from inactivated bacteria known as Streptococcus pyogenes. It is delivered directly into the bladder through a procedure called intravesical instillation, which means the medication is placed directly inside the bladder rather than taken by mouth or through an injection into the bloodstream.
Main inclusion criteria: Participants must be at least 18 years old and have a confirmed diagnosis of high-grade non-muscle invasive bladder cancer with active disease. The study includes two groups: Cohort A includes patients whose cancer cannot be treated with BCG treatment or who haven’t received BCG for 24 months before diagnosis, while Cohort B includes patients whose cancer did not respond to BCG treatment within 12 months after completing it. Participants must have an ECOG performance status of 0, 1, or 2, which measures their ability to carry out daily activities. Women of childbearing age must have a negative pregnancy test and use reliable birth control during the study and for 4 weeks afterward. Men who are sexually active must also use birth control and cannot donate sperm during this time. Patients must not have received other investigational bladder cancer treatments for at least 6 weeks before joining the study.
Main exclusion criteria: Patients cannot participate if their bladder cancer has spread into the muscle layer of the bladder wall. Those who cannot undergo necessary procedures like cystoscopy, bladder biopsy, or urine cytology are excluded. The study also excludes vulnerable populations who may need special protection.
Focus and goal: The trial aims to evaluate both the safety and effectiveness of TARA-002 in treating high-grade non-muscle invasive bladder cancer. The study follows a structured approach beginning with an initial treatment phase where TARA-002 is administered according to a specific schedule. Throughout the treatment, participants undergo regular monitoring through cystoscopy, bladder biopsies, and urine tests to assess how well the treatment is working and to check for side effects. The study measures complete response rates at various time points and tracks how long any positive responses last. After the active treatment phase, participants enter a follow-up period where doctors continue to monitor for any long-term effects, cancer recurrence, overall survival, and changes in quality of life.
Investigational drug: TARA-002 is an immunotherapy agent that works by stimulating the immune system to attack cancer cells. It is prepared from a lyophilized powder for injection and is administered directly into the bladder. The exact molecular mechanism is still under investigation, but the treatment aims to enhance the body’s natural defenses against cancer. The study will carefully evaluate this medication’s ability to reduce or eliminate bladder tumors while monitoring participants closely for any adverse effects.
Summary
Currently, there is only one clinical trial available for patients with bladder cancer stage 0 with cancer in situ. This trial is being conducted in two European countries: Romania and Spain. The study focuses on testing TARA-002, an investigational immunotherapy treatment made from inactivated bacteria that is delivered directly into the bladder. This trial is particularly important for patients whose cancer has not responded to standard BCG treatment or who cannot receive BCG therapy. The study employs comprehensive monitoring procedures including cystoscopy, biopsies, and urine tests to carefully evaluate both the safety and effectiveness of this novel treatment approach.