Spots Global Cancer Trial Database for ADSTILADRIN (=INSTILADRIN) in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
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Trial Identification
Brief Title: ADSTILADRIN (=INSTILADRIN) in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Official Title: A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN® (rAd-IFN)/Syn3) Administered Intravesically to Patients With High Grade, BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Study ID: NCT02773849
Conditions
Interventions
Study Description
Brief Summary: Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC. This Phase III study is designed to expand those observations using a high dose of ADSTILADRIN in patients that are "BCG Unresponsive" which refers to patients with high-grade NMIBC who are unlikely to benefit from and should not receive further intravesical BCG.
Detailed Description: Recombinant IFN alpha2b has pleiotropic effects that contribute to antitumor activity in Non-Muscle Invasive Bladder Cancer (NMIBC). ADSTILADRIN is a non-replicating adenovirus vector harboring the human IFN alpha2b gene. When combined with the excipient Syn3, intravesical administration of the rAd-IFN results in transduction of the virus into the epithelial cell lining in the bladder. The IFN alpha2b gene is incorporated into the cellular DNA resulting in the synthesis and expression of large amounts of IFN alpha2b protein. Clinical studies have confirmed that IFN alpha2b protein can be measured in the urine of patients treated with ADSTILADRIN within 24 hours after dosing.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Keck School of Medicine at USC Medical Center, Los Angeles, California, United States
The Urology Center of Colorado, Denver, Colorado, United States
University of Florida - UF Health Davis Center Pavilion and Shands Med Plaza, Gainesville, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Emory University School of Medicine, Atlanta, Georgia, United States
University of Chicago - Comprehensive Cancer Research Center, Chicago, Illinois, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Johns Hopkins Kimmel Cancer Center, Baltimore, Maryland, United States
University of Michigan, Ann Arbor, Michigan, United States
Spectrum Health Medical Group, Grand Rapids, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Delaware Valley Urology, LLC, Voorhees, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
SUNY Upstate Medical Center, Syracuse, New York, United States
University of North Carolina (UNC) - Chapel Hill, Chapel Hill, North Carolina, United States
Duke University, Durham, North Carolina, United States
The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Regional Urology, Greenville, South Carolina, United States
Carolina Urologic research Center, Myrtle Beach, South Carolina, United States
Vanderbilt University Medical Center Dept. of Urologic Surgery, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
The Univ. of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
University of Virginia Health System, Charlottesville, Virginia, United States
Urology of Virginia, Virginia Beach, Virginia, United States
West Virginia University Cancer Institute, Morgantown, West Virginia, United States
University of Wisconsin - Madison, Madison, Wisconsin, United States
Contact Details
Name: Stephen Boorjian, MD
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
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