A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MITOGEL™ (mitomycin) urothelial gel, 0.4% on Ablation of Upper Urinary Tract Urothelial Carcinoma (NCT02793128)
The OLYMPUS trial is a phase III multicenter trial designed to assess the efficacy and safety of treatment with MITOGEL™ (mitomycin) urothelial gel, 0.4% , in the upper urinary system of patients with non-invasive low-grade, urinary tract urothelial carcinoma (UTUC). MITOGEL™ is a gel formulation of mitomycin for ureteral instillation which is designed to maintain the drug over a prolonged period in the upper urinary system in order to treat low –grade UTUC.
In this study, all eligible patients will receive MITOGEL™ instillations into upper urinary tract once per week for 6 weeks. The administration of MITOGEL™ will be performed through a standard ureteral catheter. If the tumor(s) disappear after 6 instillations, patients will receive up to an additional 11 (eleven) maintenance treatments.
The OLYMPUS trial is based on safety and efficacy results from a Compassionate Use Program in patients with severe, non-resectable, low-grade UTUC, demonstrating complete response (no visible disease confirmed by negative cytology) in over 60% of the evaluated patients that completed treatment, showing the potential chemoablative effects of MITOGEL™. In addition, these patients demonstrated lower recurrence episodes following MITOGEL™ treatment.
MAIN ELIGIBILITY CRITERIA
Inclusion criteria (partial list):
- Patients with upper tract urothelial carcinoma (UTUC)
- Patients with low grade tumor
Exclusion criteria (partial list):
- Patient received BCG treatment during the 6 months prior to the study
- Patient has carcinoma in situ in the past in the urinary tract.
- Patient has a history of invasive urothelial carcinoma in the urinary tract during the past 5 (Five) years.
- Patient has an history of high grade papillary urothelial carcinoma in the urinary tract during the past 2 (Two) years.
- Patient is being treated with systemic chemotherapy
Medical centers in USA and Israel have opened the OLYMPUS study for patient enrollment.
CLINICAL SITES RECRUITING PATIENTS
Alaska Urological Institute
Anchorage, Alaska, United States, 99503
Contact: Josh Logan, MD
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Contact: Mitchell Humphreys, M.D.
Contact: Cher-yee Lye 480-342-6012 Lye.Cher-Yee@mayo.edu
University of California
Davis, California, United States, 95616
Contact: Marc Dall’Era, MD
Loma Linda Cancer Center
Loma Linda, California, United States, 92354
Contact: Brian Hu, M.D.
Contact: Arielle Dennis
University of California
Los Angeles, California, United States, 90095
Contact: Karim Chamie, MD
Providence Medical Institute
Santa Monica, California, United States, 90404
Contact: Jennifer Linehan, M.D.
Contact: Dorreth King-Rucker
(310) 582-7138 Dorreth.King-Rucker@providence.org
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Contact: Raymond Pak, M.D.
Contact: Katie Custer Custer.Kaitlynn@mayo.edu
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Contact: Hristos Kaimakliotis, M.D.
Contact: Courtney Dhondt
University of Iowa
Iowa City, Iowa, United States, 52242
Contact: Mike O’Donnell, M.D.
Contact: Janelle Born
John Hopkins University
Baltimore, Maryland, United States, 21218
Contact: Phillip Pierorazio, MD
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Contact: Alon Weizer, M.D.
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Contact: Christopher Weight, M.D.
Contact: Therese Perrier 612-625-3319 firstname.lastname@example.org
Mayo Clinic health system
Rochester, Minnesota, United States, 55905
Contact: Lance Mynderse, M.D.
Contact: Tessa Kroeninger 507-284-1724 Kroeninger.Tessa@mayo.edu
Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center
New York, New York, United States, 10032-3784
Contact: Ojas Shah, M.D.
Contact: Anna Rodriguez
Weill Cornell Medical Center
New York, New York, United States, 10065
Contact: Douglas S Scherr, MD
Montefiore Medical Center (Albert Einstein)
The Bronx, New York, United States, 10467
Contact: Joshua Stern, MD
University of north carolina – Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Contact: Michael Woods, MD
Cleveland, Ohio, United States, 44195
Contact: Andrew Stephenson, M.D.
Contact: Joanna Homann (216) 444-0124 HOMANNJ@ccf.org
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Contact: Ahmad Shabsigh, MD
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Contact: Jay Raman, M.D.
Contact: Kathleen Lehman (717) 531-5930 Klehman3@pennstatehealth.psu.edu
Thomas Jefferson University Hospitals
Philadelphia, Pennsylvania, United States, 19107
Contact: Scott Hubosky, M.D.
Contact: Katherine Burns (215) 520-0189 katherine.Burns@jefferson.edu
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jefferey Gingrich, MD
Houston, Texas, United States, 77006
Contact: Surena Matin, MD
Baylor College of Medicine
Houston, Texas, United States, 77030
Contact: Guilherme Godoy, MD
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Contact: Michael Williams, M.D.
Contact: Michele Schindler (757) 452-3465 email@example.com
Sheba Medical Center, Israel
Ramat Gan, Israel, 52621
Contact: Nir Kleinmann, M.D.
Contact: Dafna Ben-Yaacov, Phd 972-3-5307363 Dafna.BenYaacov@sheba.health.gov.il
For further information please visit:
For physicians interested in participating, please contact Dr Ifat Klein firstname.lastname@example.org