Talimogene Laherparepvec in Treating Patients With Non-Muscle Invasive Bladder Transitional Cell … (NCT03430687) | Clinical Trial Compass
WithdrawnPhase 1
Talimogene Laherparepvec in Treating Patients With Non-Muscle Invasive Bladder Transitional Cell Carcinoma
Stopped: Investigators prefer to pursue other studies
United States0Started 2018-06-01
Plain-language summary
This phase I trial studies the side effects and best dose of talimogene laherparepvec and to see how well it works in treating patients with non-muscle invasive bladder transitional cell carcinoma. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically document transitional cell carcinoma with the presence of any of the following stages: carcinoma in situ (CIS), high-grade Ta, or any grade T1, detectable at the time of study accrual; combinations of the aforementioned stages are acceptable; subjects with mixed histology are required to have a dominant transitional cell carcinoma (TCC) pattern
* Failure of prior intravesical treatment(s), one of which must include a course of BCG; failure is defined as evidence of TCC on cystoscopic examination and biopsy or cystoscopic examination and urine cytology at least 6 weeks from completion of last treatment
* Patient is either ineligible for or declines radical cystectomy; the investigator must explain that a delay in cystectomy may increase the patient?s chance of disease progression
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
* Ability to understand and willingness to sign written informed consent
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \< 2.5 x institutional upper limit of normal (ULN) and total bilirubin \< 1.5 x institutional ULN
* Absolut neutrophil count (ANC) \> 1500/uL
* Platelets \>= 75,000/uL
* Hemoglobin \> 8 mg/dL without need for hematopoetic growth factor or transfusion support
* Estimated glomerular filtration rate (GFR) \> 30 ml/min
* Serum creatinine less than 1.5 x upper limit of normal (ULN), OR 24-hour creatinine clearance = or 60 mL/min for subject with creatinine levels …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of treatment-related toxicities according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (Dose escalation)
Timeframe: Up to 2 years
2
Pathologic T0 rate (Dose expansion)
Timeframe: At 6 months
3
Relapse-free survival rate (Dose expansion)
Timeframe: From study start until recurrence of disease or death from any cause, assessed at 2 years