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Spots Global Cancer Trial Database for Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure

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Trial Identification

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

Conditions

Bladder Cancer

Interventions

CG0070

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Gary Steinberg, MD

Affiliation: University of Chicago

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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