Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC Patients

This is an interventional treatment trial for Bladder Cancer focused on measuring TC-3 Gel, MMC, NMIBC, Non Muscle Invasive Bladder Cancer, Hydrogel Reverse thermal gelation, Drug retention, Urinary Bladder Neoplasms, Urologic Neoplasms, Urinary Bladder Diseases, Urologic Diseases Read More

Inclusion Criteria:

• Patient is 18 years of age or older.
• Patient has signed Informed Consent Form and is willing and able to abide by the protocol.
• Patients diagnosed with Low Grade (LG) or High grade (HG) NMIBC.
• No active urinary tract infection as confirmed by urine culture.
• If the patient is a female of childbearing potential, she is using two acceptable & effective methods of contraception, until 6 months post treatment
• A negative serum pregnancy test at screening for female patient with childbearing potential
• If the patient is a male he should use a condom during intercourse, for at least 48 hours post each instillation.
• If the patient is a male that has a partner that is a female of childbearing potential, he should be advised to use two acceptable & effective methods of contraception until 6 months post treatment.

Exclusion Criteria:

• Tumor located in prostatic urethra (for male patient) or in the bladder diverticulum.
• Prior or required pelvic radiotherapy.
• Systemic chemotherapy within 1 year prior the screening.
• Pregnant or breastfeeding female patient.
• Treatment of bladder cancer with BCG within the last 12 months prior to screening visit . Exception: For patient that had BCG treatment within 6-12 months prior to screening visit and are not symptomatic, the patient may enroll at the investigator discretion.
• Treatment (full course) with intravesical chemotherapy within the 3 months, prior to screening visit.
• Contraindication to MMC treatment as per investigator determination, or known sensitivity to MMC or TC-3 ingredients.
• The patient has a known current urinary retention which requires intermittent catheterization to empty the bladder.
• The patient has a bleeding disorder or a screening platelet count <100X109/L.
• The patient has screening hemoglobin <10g/dL OR white blood cells < 4000 mm3.
• GFR<30
• Hepatic values exceeding 2 times the upper normal limit.
• The patient has a concurrent severe and/or uncontrolled medical condition (e.g., uncontrolled diabetes, compensated congestive heart failure [NYHA III and over], myocardial infarction within 6 months of screening visit, unstable or uncontrolled hypertension or an active uncontrolled infection) or psychiatric disease, which could compromise participation, compliance with scheduled visits, and/or completion of the study in the opinion of the investigator.
• The patient has a documented severe vesico-ureteral reflux or has an in-dwelling ureteral stent.
• The patient participated in an investigational interventional study within the past 90 days, prior to screening visit.