Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

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.