A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel™ on Ablation of Upper Urinary Tract Urothelial Carcinoma

The OLYMPUS trial is a phase III multicenter trial designed to assess the efficacy and safety of treatment with MitoGel™ (mitomycin) for instillation, 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, eligible patients will receive 6 MitoGel instillations of MitoGel 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    907-276-1455    Joshuaelogan@gmail.com

Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Contact: Mitchell Humphreys, M.D.    480-342-2951    humphreys.mitchell@mayo.edu
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    916-734-2893    mdallera@ucdavis.edu

Loma Linda Cancer Center
Loma Linda, California, United States, 92354
Contact: Brian Hu, M.D.       BHu@llu.edu
Contact: Arielle Dennis    909-558-4050    ardennis@llu.edu

University of California
Los Angeles, California, United States, 90095
Contact: Karim Chamie, MD    310-206-8183    kchamie@mednet.ucla.edu

Providence Medical Institute
Santa Monica, California, United States, 90404
Contact: Jennifer Linehan, M.D.       Jennifer.Linehan@providence.org
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.    404-683-5298    Pak.Raymond@mayo.edu
Contact: Katie Custer       Custer.Kaitlynn@mayo.edu

Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Contact: Hristos Kaimakliotis, M.D.       hkaimakl@iupui.edu
Contact: Courtney Dhondt    317.274.1791    cgerler@iu.edu

University of Iowa
Iowa City, Iowa, United States, 52242
Contact: Mike O’Donnell, M.D.       michael-odonnell@uiowa.edu
Contact: Janelle Born    319-356-4797    Janelle-born@uiowa.edu

John Hopkins University
Baltimore, Maryland, United States, 21218
Contact: Phillip Pierorazio, MD    410-955-6850    philpierorazio@jhmi.edu

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Contact: Alon Weizer, M.D.       aweizer@umich.edu
Contact       bksmith@umich.edu

University of Minnesota
Minneapolis, Minnesota, United States, 55455
Contact: Christopher Weight, M.D.    734-232-0061    cjweight@umn.edu
Contact: Therese Perrier    612-625-3319    perri084@umn.edu

Mayo Clinic health system
Rochester, Minnesota, United States, 55905
Contact: Lance Mynderse, M.D.    507-284-2297    Mynderse.lance@mayo.edu
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.       os2302@cumc.columbia.edu
Contact: Anna Rodriguez    212-305-1371    ar2442@cumc.columbia.edu

Weill Cornell Medical Center
New York, New York, United States, 10065
Contact: Douglas S Scherr, MD    212-746-5788    dss2001@med.cornell.edu

Montefiore Medical Center (Albert Einstein)
The Bronx, New York, United States, 10467
Contact: Joshua Stern, MD    347-842-1715    jstern@montefiore.org

University of north carolina – Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Contact: Michael Woods, MD    919-537-3505    Michael_woods@med.unc.edu

Duke University
Durham, North Carolina, United States, 27708
Contact: Brant Inman, M.D.    919-684-1322    brant.inman@duke.edu
Contact: Mary Motta    919-681-3675    mary.motta@duke.edu

Cleveland Clinic
Cleveland, Ohio, United States, 44195
Contact: Andrew Stephenson, M.D.    216-444-0124    stephea2@cccf.org
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    614-293-7833    ahmad.shabsigh@osumc.edu

Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Contact: Jay Raman, M.D.    717-531-6979    jraman@hmc.psu.edu
Contact: Kathleen Lehman    (717) 531-5930    Klehman3@pennstatehealth.psu.edu

Thomas Jefferson University Hospitals
Philadelphia, Pennsylvania, United States, 19107
Contact: Scott Hubosky, M.D.    215-955-1000    scott.hubosky@jefferson.edu
Contact: Katherine Burns    (215) 520-0189    katherine.Burns@jefferson.edu

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jefferey Gingrich, MD    412-605-3015    gingrichjr@upmc.edu

MD Anderson
Houston, Texas, United States, 77006
Contact: Surena Matin, MD    713-792-3250    surmatin@mdanderson.org

Baylor College of Medicine
Houston, Texas, United States, 77030
Contact: Guilherme Godoy, MD    713-798-7296    godoy@bcm.edu

Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Contact: Michael Williams, M.D.       MichaelWilliams@urologyofva.net
Contact: Michele Schindler    (757) 452-3465    mschindler@urologyofva.net

Sheba Medical Center, Israel
Ramat Gan, Israel, 52621
Contact: Nir Kleinmann, M.D.    952-53-3398845    nir.kleinmann@gmail.com
Contact: Dafna Ben-Yaacov, Phd    972-3-5307363    Dafna.BenYaacov@sheba.health.gov.il

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