Status:
WITHDRAWN
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)
Lead Sponsor:
UroGen Pharma Ltd.
Conditions:
Non Muscle Invasive Bladder Cancer
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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 follo...
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 such a...
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.
- Single or multiple tumors (n≤7)
- Naïve or Recurrent tumor
- No prior history of HG and/or T1 and/or Tis
- At least one Tumor ≥ 1mm as evaluated visually by the investigator
- Largest tumor diameter ≤ 30mm as evaluated visually by the investigator
- Cystoscopic appearance of papillary Low grade tumor
- The patient had upper urinary tract evaluation in the previous year excluding urothelial carcinoma, hydronephrosis or Renal Cell Carcinoma or other renal cancers.
- Good performance status (Karnofsky performance status 70% or greater).
- No active urinary tract infection as confirmed by urine culture.
- 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
- Carcinoma In Situ (CIS).
- Over 7 lesions
- Lesion is larger than 30mm in diameter.
- "High Grade" urine cytology.
- Cystoscopic Appearance suspicious for HG and/or solid and/or Tis
- histologic results of cold cup biopsy are indicative of HG tumor.
- Tumor located in prostatic urethra.
- Previous systemic chemotherapy or pelvic radiotherapy.
- Pregnant or breastfeeding patient.
- Previous treatment with BCG within the last 24 months.
- The patient did not have at least 3 months cystoscopically confirmed tumor-free interval between the last tumor recurrence and screening.
- Treatment with intravesical chemotherapy within the 3 last months.
- The patient has/had any bladder tumor with histology other than TCC
- Contraindication to MMC.
- 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).
- The patient has a bleeding disorder or a screening platelet count \<50X109/L.
- The patient has screening hemoglobin \<10mg/dL.
- The patient has a history of Acquired Immunodeficiency Syndrome or HIV positive.
- 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.
- The patient participated in an investigational protocol within the past 90 days.
- The patient has life expectancy of \<3 years.
- 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
- The patient has documented vesica-ureteral reflux or an indwelling ureteral stent
- The patient has the tumor in the bladder diverticulum
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01799499
Start Date
March 1 2013
End Date
March 1 2013
Last Update
September 1 2015
Active Locations (1)
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1
Western Galilee Hospital Nahariya
Nahariya, Israel