Evaluation of NanoDoce® in Participants With Urothelial Carcinoma
Bladder Cancer, Urothelial Carcinoma, Urinary Bladder Neoplasm
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring non-muscle invasive bladder cancer, muscle invasive bladder cancer, high-risk bladder cancer, BCG-unresponsive bladder cancer, BCG failure, BCG-refractory bladder cancer, BCG-resistant bladder cancer, NMIBC, MIBC
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent;
- Age ≥18 years;
Patients with either:
- High-risk Non-Muscle Invasive Bladder Cancer (NMIBC);
- Muscle Invasive Bladder Cancer (MIBC);
- Urothelial carcinoma confirmed by biopsy, urine cytology, computed tomography scan (CT) or other institution-approved diagnostic methodology;
- All visible tumors removed during bladder resection (TURBT);
- Performance Status (ECOG) 0-2 at study entry;
- Life expectancy of at least 6 months;
Adequate marrow, liver, and renal function;
- ANC ≥ 1.5 x 10^9/L;
- Hemoglobin ≥ 9.5 grams/dL;
- Platelets ≥ 75 x 10^9/L;
- Total bilirubin ≤ 1.5x institutional ULN;
- AST/ ALT ≤ 2.5x institutional ULN;
- Creatinine ≤ 1.5x institutional ULN;
- Adequate method of birth control.
Exclusion Criteria:
- Metastatic disease;
- Previous (within 12 months) or concurrent history of non-bladder malignancy, except for non-melanoma skin cancer;
- Intravesical therapy within 6 weeks prior to consent (chemotherapy or immunotherapy including BCG administered directly into the bladder);
- Resection surface area greater than 8 cm2;
- Upper tract and urethral disease within 18 months;
- Known hypersensitivity to any of the study drug components or reconstitution components;
- Pregnant or breastfeeding;
- Participation in the treatment phase of another clinical trial within 3 months prior to consent;
- Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;
- Ongoing drug or alcohol abuse.
Sites / Locations
- BCG Oncology, PC
- James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions
- Columbia University Herbert Irving Comprehensive Cancer Center
- Carolina Urologic Research Center
- UT Health San Antonio
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Non-Muscle Invasive Bladder Cancer
Muscle Invasive Bladder Cancer
Subjects will be enrolled in sequential, dose escalating cohorts of NanoDoce direct injection (0.75, 1.5, 2.5, or 3.75 mg/mL). Subjects will also receive an initial NanoDoce intravesical instillation at 2.0 or 3.0 mg/mL and additional Induction (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest) and Maintenance (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest) instillations at 2.0 or 3.0 mg/mL.
Subjects will be enrolled in sequential, dose escalating cohorts of NanoDoce direct injection (0.75, 1.5, 2.5, or 3.75 mg/mL). Subjects will also receive an initial NanoDoce intravesical instillation at 2.0 or 3.0 mg/mL. Subjects will then go on to receive institutional standard of care.