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The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study

Overview

Información sobre este estudio

The study is investigating the ability of UroGen's MitoGel™ procedure to treat urothelial carcinoma tumors from the upper urinary tract. If this treatment will prove to be effective this will lead to the development of a new treatment approach for patients suffering from Low Grade Upper Urinary Urothelial Carcinoma (UTUC).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Main Inclusion Criteria:

  1. Patient is at least 18 years of age.
  2. Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system.
  3. Patient has at least one (1) measurable and biopsy-confirmed papillary LG tumor, evaluated visually, ≤ 15 mm. The largest lesion should not exceed 15mm.
  4. Following biopsy patient should have at least one remaining lesion with a diameter of 5 mm.
  5. Patient with bilateral LG UTUC may be enrolled if at least one side meets the inclusion criteria for the trial and if the other kidney does not require further treatments (The other kidney can be treated prior to the beginning of the study).

Main Exclusion Criteria:

  1. Patient received BCG treatment for UC during the 6 months prior to Visit 1.
  2. The patient has untreated concurrent urothelial cancer in other locations other than the target area (unless treated during screening)
  3. CIS in the past in the urinary tract.
  4. Patient has a history of invasive urothelial carcinoma in the urinary tract during the past 5 (Five) years.
  5. Patient has a history of high grade papillary urothelial carcinoma in the urinary tract during the past 2 (Two) years.
  6. Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Raymond Pak, M.D., M.B.A.

Cerrado para la inscripción

Contact information:

Rachel Pung Page

White.Rachel2@mayo.edu

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Mitchell Humphreys, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20391188

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