In This SectionTexas Health Research & Education Institute
Clinical Trials
Disease or Condition
Bladder Cancer
Title
EOQUIN® AS A SURGICAL ADJUVANT OF NONINVASIVE BLADDER CANCER (Bladder Cancer)
Description
This study is to study drug Eoquin and its ability to prevent or delay a return of low-grade bladder cancer following surgery.
IRB Number
Pro160
Inclusion/Notes
INCLUSION:
Has the patient given written informed consent?
Is the patient at least 18 years old?
Does the patient have transitional cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2?
If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days?
Is the patient willing and able to abide by the protocol?
EXCLUSION:
Does the patient have more than 4 bladder tumors?
Does any single bladder tumor exceed 3.5 cm in diameter?
Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor <0.5 cm?
Has the patient ever received EOquin??
Does the patient have, or has the patient ever had, any bladder tumor known to be other than stage Ta or grade G1 or G2 (low grade [WHO/ISUP classification]).
Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma?
Does the patient have, or has the patient ever had, CIS?
Does the patient have an active urinary tract infection?
Does the patient have a bleeding disorder or a screening platelet count < 100 x 109/L?
Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo TUR-BT under general or spinal anesthesia?
Does the patient have a screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 109/L or a screening creatinine > 2 mg/dL?
Does the patient have a known immunodeficiency disorder?
Has the patient received any investigational treatment within the past 30 days?
Is the patient breast feeding?
Does the patient have a history of interstitial cystitis?
Does the patient have a history of allergy to red color food dye?
Has the patient had transitional cell carcinoma of the bladder within the past 4 months?
