A Prospective Open Label Comparative Dose Ranging Study Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) (NMIBC TURBT HG)

This is an interventional treatment trial for Non Muscle Invasive Bladder Cancer focused on measuring Non Muscle Invasive Bladder Cancer, Intravesical instillation, Mitomycin C, Hydrogel, Reverse thermal gelation, Drug retention, Urinary Bladder Neoplasms, Carcinoma, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Urinary Bladder Diseases, Urologic Diseases, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type Mitomycins, Mitomycin, Antibiotics, Antineoplastic, Antineoplastic Agents, Therapeutic Uses, Pharmacologic Actions, Nucleic Acid Synthesis Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Alkylating Agents Read More

Inclusion Criteria:

1. Patient is 21 years of age or older.
2. Patient has signed Informed Consent Form and is willing and able to abide by the protocol.
3. Single or multiple tumors (n≤7)
4. Naïve or Recurrent tumor
5. No prior history of HG and/or T1 and/or Tis
6. At least one Tumor ≥ 1mm as evaluated visually by the investigator
7. Largest tumor diameter ≤ 30mm as evaluated visually by the investigator
8. Cystoscopic appearance of papillary Low grade tumor
9. The patient had upper urinary tract evaluation in the previous year excluding urothelial carcinoma, hydronephrosis or Renal Cell Carcinoma or other renal cancers.
10. Good performance status (Karnofsky performance status 70% or greater).
11. No active urinary tract infection as confirmed by urine culture.
12. If the patient is a female of childbearing potential she is using an acceptable/effective method of contraception and has a negative pregnancy test at screening.

Exclusion Criteria:

1. Carcinoma In Situ (CIS).
2. Over 7 lesions
3. Lesion is larger than 30mm in diameter.
4. "High Grade" urine cytology.
5. Cystoscopic Appearance suspicious for HG and/or solid and/or Tis
6. histologic results of cold cup biopsy are indicative of HG tumor.
7. Tumor located in prostatic urethra.
8. Previous systemic chemotherapy or pelvic radiotherapy.
9. Pregnant or breastfeeding patient.
10. Previous treatment with BCG within the last 24 months.
11. The patient did not have at least 3 months cystoscopically confirmed tumor-free interval between the last tumor recurrence and screening.
12. Treatment with intravesical chemotherapy within the 3 last months.
13. The patient has/had any bladder tumor with histology other than TCC
14. Contraindication to MMC.
15. The patient has a history of urinary retention or a PVR≥250cc by bladder scan or ultrasound (PVR test may be repeated up to 3 times).
16. The patient has a bleeding disorder or a screening platelet count <50X109/L.
17. The patient has screening hemoglobin <10mg/dL.
18. The patient has a history of Acquired Immunodeficiency Syndrome or HIV positive.
19. The patient has a condition or a concurrent severe and/or uncontrolled medical or psychiatric disease (e.g. uncontrolled diabetes, compensated congestive heart failure (NYHA III and over), myocardial infarction within 6 months of study, unstable or uncontrolled hypertension or an active uncontrolled infection), which according to the PIs decision could compromise participation, compliance with scheduled visits and/or completion.
20. The patient participated in an investigational protocol within the past 90 days.
21. The patient has life expectancy of <3 years.

22. The patient had another malignancy or received therapy for any malignancy in the last five years except for:

    • Non-melanoma skin tumors
    • stage 0 (in situ) cervical carcinoma
    • prostatic carcinoma
23. The patient has documented vesica-ureteral reflux or an indwelling ureteral stent
24. The patient has the tumor in the bladder diverticulum