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Brief Title: Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure
Official Title: An Open Label, Single Arm, Phase II, Multicenter Study of the Safety and Efficacy of CG0070 Oncolytic Vector Regimen in Patients With Non-Muscle Invasive Bladder Carcinoma Who Have Failed BCG (Bacillus Calmette-Guerin) Therapy and Refused Cystectomy
Study ID: NCT02365818
Brief Summary: To study the safety and efficacy of CG0070, an oncolytic virus expression GM-CSF in high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy.
Detailed Description: The plan is to study the safety and efficacy of CG0070 in high-grade NMIBC (Non-muscle Invasive Bladder Cancer) patients who failed BCG therapy. Most patients with NMIBCis (Cis, Cis with Ta and/or T1, high grade Ta or T1 with frequent or uncontrolled recurrences) who have failed BCG (Bacillus Calmette-Guerin) intravesical therapy (standard of care) usually have no other choice but to proceed to cystectomy. Cystectomy is a surgery associated with major morbidity, mortality and quality of life issues. Morbidity and long term tedious medical care will be for the rest of the patient's life span. Most patients at this stage do not show signs of disease progression into the muscle layer or of metastasis, making surgery a very difficult decision. CG0070, if successful in this trial, will serve to provide a therapeutic alternative for this patient population in need.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Alaska Clinical Research Center, Anchorage, Alaska, United States
BCG Oncology, Phoenix, Arizona, United States
Arizona Institute of Urology, Tucson, Arizona, United States
Institute of Urologic Oncology at UCLA, Los Angeles, California, United States
UC Irvine Medical Center, Orange, California, United States
University of California, San Diego, San Diego, California, United States
UF Health Cancer Center, Gainesville, Florida, United States
University of Chicago, Chicago, Illinois, United States
Michigan Institute of Urology, P.C., Troy, Michigan, United States
Adult Pediatric Urology and Urogynecology, PC, Omaha, Nebraska, United States
GU Research Network/ The Urology Center, Omaha, Nebraska, United States
Premier Urology Group, LLC., Edison, New Jersey, United States
Premier Medical Group of the Hudson Valley, Poughkeepsie, New York, United States
Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States
The Urology Group, Cincinnati, Ohio, United States
Vanderbilt University Medical Center, Dept. of Urologic Surgery, Nashville, Tennessee, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Name: Gary Steinberg, MD
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR