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)
- Conditions
- Non-Muscle Invasive Bladder Cancer (NMIBC)superficial bladder cancer1003836410004994
- Registration Number
- NL-OMON38450
- Lead Sponsor
- Sintesi Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
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. 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
13. If the patient is a female of childbearing potential she 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. First presentation of bladder tumor
5. High Grade urine cytology
6. Tumor located in prostatic urethra
7. Previous systemic chemotherapy or pelvic radiotherapy
8. Pregnant or breastfeeding patient
9. Previous treatment with BCG within the last 24 months
10. The patient did not have at least 3 months cystoscopically confirmed tumor-free interval between the last tumor recurrence and screening
11. Treatment with intravesical chemotherapy within the 3 last months
12. The patient has/had any bladder tumor with histology other than TCC
13. Contraindication to MMC
14. 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)
15. The patient has a bleeding disorder or a screening platelet count <50X109/L
16. The patient has screening hemoglobin <10mg/dL
17. The patient has a history of Acquired Immunodeficiency Syndrome or HIV positive
18. 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 could compromise participation, compliance with scheduled visits and/or completion
19. The patient participated in an investigational protocol within the past 90 days
20. The patient has life expectancy of <3 years
21. 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
22. The patient has documented vesico-ureteral reflux or an indwelling ureteral stent
23. The patient has the tumor in the bladder diverticulum
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Cystoscopic and pathological effect (evaluated at TUR-BT visit) of pre-TURBT<br /><br>intravesical instillations with 40mg of MMC mixed with 60cc TC-3 Hydrogel on<br /><br>bladder lesion(s) of NMIBC patients.<br /><br><br /><br>Demonstration of Pre-TURBT TC-3 gel-MMC instillation safety and adverse event<br /><br>rate.<br /><br><br /><br>(pag 22-24 of the protocol)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Comparison of the cystoscopic and pathological effect of pre-TURBT<br /><br>instillations with MMC mixed with TC-3 Hydrogel on bladder lesion(s) to that of<br /><br>pre-TURBT MMC in water instillation.<br /><br><br /><br>Comparison of one year tumor recurrence rate between both treatment groups.<br /><br><br /><br>Demonstration that blood levels of MMC following Pre-TURBT TC-3 gel-MMC<br /><br>instillation are below the toxic level (400ng/ml) known in the art for IV MMC<br /><br>administration..<br /><br><br /><br>(pag 25 of the protocol)</p><br>