Status:
COMPLETED
Pre-TURBT TC-3 Gel Intravesical Instillation in NMIBC
Lead Sponsor:
UroGen Pharma Ltd.
Conditions:
Carcinoma of Urinary Bladder, Superficial
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
In the proposed study the investigators aim to evaluate the effect of the standard of care dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low risk recurrent N...
Detailed 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 as Mit...
Eligibility Criteria
Inclusion
- Patient is 21 years of age or older.
- Patient has signed Informed Consent Form and is willing and able to abide by the protocol.
- Naïve or recurrent low grade (LG) NMIBC tumor
- Recurrent patients - Single or multiple tumors
- Naive patients - 2 tumors or above
- No prior history of HG and/or T1 in the past 5 years.
- No prior history of Tis
- At least one Tumor ≥ 1 mm as evaluated visually by the investigator.
- Largest tumor diameter ≤ 30 mm as evaluated visually by the investigator
- Cystoscopic appearance of papillary Low grade tumor
- 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
- 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
- Carcinoma In Situ (CIS).
- "High Grade" urine cytology which is conclusive for HG.
- "High Grade" tumor results in cold cup biopsy.
- Tumor located in prostatic urethra.
- Previous systemic chemotherapy in the last 2 years or pelvic radiotherapy.
- Pregnant or breastfeeding patient.
- Previous treatment with BCG within the last 12 months.
- The patient did not have at least 3 months cystoscopically confirmed tumor-free interval between the last TURBT to current tumor recurrence.
- Treatment with full course of intravesical chemotherapy within the 3 last months.
- The patient has/had any bladder tumor with histology other than TCC.
- Known contraindication or hypersensitivity to MMC or gel.
- The patient has a known history of upper urinary tract urothelial carcinoma, or Renal Cell carcinoma or other renal cancer.
- The patient has a known urinary retention which, according to the investigator's opinion, might lead to avoid patient receiving the treatment.
- The patient has a bleeding disorder or a screening platelet count \<50X109/L.
- The patient has screening hemoglobin \<10 mg/dL.
- 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.
- The patient participated in an investigational interventional study within the past 90 days.
- The patient has documented sever vesico-ureteral reflux or an indwelling ureteral stent.
- The patient has the tumor in the bladder diverticulum.
- The patient participated in a prior TheraCoat's trial with MMC and TC-3
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01803295
Start Date
June 1 2013
End Date
June 1 2017
Last Update
June 16 2017
Active Locations (13)
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1
Carmel Medical Center of Haifa, Department of Urology
Haifa, Israel
2
Rambam Health Care Campus
Haifa, Israel
3
Wolfson Medical Center of Holon, Department of Urology
Holon, Israel
4
Meir medical center
Kfar Saba, Israel