Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01799499
Other study ID # PRE-TURBT-DR-PRO
Secondary ID
Status Withdrawn
Phase N/A
First received February 21, 2013
Last updated August 30, 2015
Start date March 2013
Est. completion date March 2013

Study information

Verified date August 2015
Source UroGen Pharma Ltd.
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

This study is a prospective randomized open labeled dose ranging comparative study. Twenty four (24) patients with NMIBC who meet the inclusion/exclusion criteria will be recruited for the study following the initial diagnostic cystoscopy.

The investigators believe that this study is of importance on several aspects:

1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the current instillation mode.

2. If proved effective, this mode of treatment might save the need for TURBT performance and serve as a new mode of tumor ablation.

3. Even if proved partially effective, this mode of treatment will diminish tumors size and/or number, thus enable a more limited TURBT procedure.

4. This mode of treatment will enable immediate medical attendance to the patient's tumor recurrence without the waiting period (resulting from queues in the medical centers) for TURBT. This might improve the patient's prognostic outcome.

5. If this experimental treatment will prove to have a better ablative effect in comparison to the standard of care known in the art, this could be translated to a better prophylactic effect of tumor recurrence.

6. Finding the minimal, yet optimal, effective dose for tumor ablation and tumor recurrence prevention will enable us to reduce adverse effects of higher drug dosage.


Description:

Non-muscle-Invasive Bladder cancer is mainly treated by tumor resection (Trans Urethral Resection - TUR), followed by series of intravesical instillations of prophylactic chemotherapeutic drugs such as Mitomycin C (MMC) or BCG. Unfortunately, this treatment approach is limited due to rapid dilution of the chemotherapeutic drug by the incoming urine and clearance by urination.

TheraCoat's core technology is based on a reverse thermal biodegradable gel (TC-3 Gel) (low viscosity at cold temperature (5°C) and gel appearance at body temperature)for drug retention in the urinary bladder.

Prior to instillation, the TC-3 Gel, in its liquid state, is mixed with MMC and instilled into the bladder by a standard catheter. Once inside the bladder, the gel solidifies and forms a drug reservoir. Upon contact with urine, the gel dissolves, release the drug slowly and is finally cleared out from the bladder.

Intravesical MMC instillation using TheraCoat's gel is expected to increase treatment efficiency due to prolongation of treatment duration and consequently improving bladder exposure to MMC.

Treatment Protocol - Immediately following baseline cystoscopy and tumor diagnosis and patient undergoes 6 weekly instillations followed by 2-4 weeks healing period.

1st Follow-Up Visit (Pre-Scheduled TURBT Visit): The patient will undergo a second cystoscopy to compare to baseline status. The patient will be followed-up for a period of 1 year as follows: 3,6,9,12 months.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
TC-3 hydrogel

TC-3 hydrogel

TC-3 hydrogel


Locations

Country Name City State
Israel Western Galilee Hospital Nahariya Nahariya

Sponsors (1)

Lead Sponsor Collaborator
UroGen Pharma Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Other Comparison of the cystoscopic and pathological effect between the 3 groups. Comparison of the cystoscopic and pathological effect of pre-TURBT instillations between the 3 different dosages of MMC mixed with TC-3 Hydro-gel groups on bladder lesion(s). 2 Years No
Other one year tumor recurrence rate Comparison of one year tumor recurrence rate between the 3 treatment groups 2 Years No
Other PK level of MMC-C in blood Demonstration that blood levels of MMC following Pre-TURBT TC-3 gel-MMC instillation are below the toxic level (400ng/ml) known in the art for IV MMC administration 1 Year Yes
Primary Ablative effect of pre-TURBT intravesical instillations with 20,40,80 mg of MMC mixed with 60cc TC-3 Hydrogel on bladder lesion(s) of NMIBC patients Cystoscopic and pathological effect (evaluated during TUR-BT visit) of pre-TURBT intravesical instillations with 20,40,80 mg of MMC mixed with 60cc TC-3 Hydrogel on bladder lesion(s) of NMIBC patients. 2 Years No
Primary Number of Participants with Adverse Events as a Measure of Safety and Tolerability rate. Demonstration of Pre-TURBT TC-3 gel-MMC instillation safety and adverse event rate.Adverse events will be defined as any adverse change in health or side effect that occurs in the clinical trial participant while the patient is receiving the treatment or until the completion of the post-treatment follow-up cystoscopy. 2 years Yes
See also
  Status Clinical Trial Phase
Completed NCT06020807 - Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
Recruiting NCT04452591 - Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin Phase 3
Recruiting NCT06167356 - Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK.
Completed NCT02343614 - Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer Phase 2
Recruiting NCT05945108 - Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER
Recruiting NCT06287541 - The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection N/A
Recruiting NCT06181266 - A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer Phase 1
Terminated NCT02982395 - Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC Phase 3
Completed NCT06205277 - Predictors of Residual Tumor at Second Transurethral Resection for pT1 Non-muscle Invasive Bladder Cancer
Completed NCT01731652 - Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer Phase 2
Recruiting NCT03421236 - Intravesical Ty21a for the Treatment of Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Phase 1
Active, not recruiting NCT04387461 - Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin Phase 2
Recruiting NCT06111235 - A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT Phase 3
Recruiting NCT02895620 - Effect on Xpert® Bladder Test of Urines Inflammatory Milieu Induced by BCG Treatment of Patients With NMIBC N/A
Completed NCT01004211 - Prospective Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging N/A
Active, not recruiting NCT05981131 - Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)