RECRUITING

ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study

Conditions

Transitional Cell Cancer of Renal Pelvis and Ureter UTUC Low Grade

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Patients will be treated with padeliporfin VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be followed up for up to an additional 48 months in the long term (non intervention) follow up phase with the specific duration depending on the patient's response to treatment

Official Title

Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (Padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer

Quick Facts

Study Start:2021-03-22

Study Completion:2029-01-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04620239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male and female patients 18 years or older * Able to understand and provide written informed consent and willing to comply with all tests and procedures associated with the study * New or recurrent low-grade, non-invasive UTUC disease * Biopsy-proven disease . A concurrence of the central pathology reader will be required for eligibility. * Up to 2 biopsy-proven sites of low-grade involvement with the largest tumor (index tumor) between 5 mm and 15 mm in diameter (as measured by endoscopy), both located in the calyces,renal pelvis or in the ureter of the ipsilateral kidney, with an absence of high-grade cells on cytology. (Ureter involvement should be in one anatomical location with no more than 20 mm of contiguous ureteral length) * Karnofsky Performance Status ≥ 50% * Adequate organ function defined at baseline as: * ANC ≥1,000/ μl, * Platelets ≥75,000/ μl, Hb ≥9 g/dl, * INR ≤ 2 * Estimated glomerular giltration rate (eGFR) ≥30 ml/min (using CKD-EPI Method) * Total serum bilirubin \<3 mg/dL, AST/ALT ≤5× upper limit of normal	* Current high-grade or muscle invasive (\>pT1) urothelial carcinoma of the bladder * Carcinoma in situ (CIS) current or previous in the upper urinary tract * History of invasive T2 or higher urothelial cancer in past 2 years * Participation in another clinical study involving an investigational product within 1 month before study entry * BCG or local chemotherapy treatment (including VEGF-targeted therapy) in the upper urinary tract within 2 months prior to inclusion * Systemic chemotherapy treatment (including VEGF-targeted therapy) within 2 months prior to enrollment * Prohibited medication that could not be adjusted or discontinued prior to study treatment * Any other medical or psychiatric co-morbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary or liver disease or current heavy smoker that, in the opinion of the study investigator, would make the patient a poor candidate for the study * Pregnant or breast-feeding women.Women of childbearing potential (WOCBP) must undergo a negative serum pregnancy test prior to study entry. * Men and women of reproductive potential not willing to observe conventional and effective birth control for the duration of treatment and for 90 days following the last padeliporfin VTP treatment.

Inclusion Criteria

Exclusion Criteria

* Male and female patients 18 years or older
* Able to understand and provide written informed consent and willing to comply with all tests and procedures associated with the study
* New or recurrent low-grade, non-invasive UTUC disease
* Biopsy-proven disease . A concurrence of the central pathology reader will be required for eligibility.
* Up to 2 biopsy-proven sites of low-grade involvement with the largest tumor (index tumor) between 5 mm and 15 mm in diameter (as measured by endoscopy), both located in the calyces,renal pelvis or in the ureter of the ipsilateral kidney, with an absence of high-grade cells on cytology. (Ureter involvement should be in one anatomical location with no more than 20 mm of contiguous ureteral length)
* Karnofsky Performance Status ≥ 50%
* Adequate organ function defined at baseline as:
* ANC ≥1,000/ μl,
* Platelets ≥75,000/ μl, Hb ≥9 g/dl,
* INR ≤ 2
* Estimated glomerular giltration rate (eGFR) ≥30 ml/min (using CKD-EPI Method)
* Total serum bilirubin \<3 mg/dL, AST/ALT ≤5× upper limit of normal

* Current high-grade or muscle invasive (\>pT1) urothelial carcinoma of the bladder
* Carcinoma in situ (CIS) current or previous in the upper urinary tract
* History of invasive T2 or higher urothelial cancer in past 2 years
* Participation in another clinical study involving an investigational product within 1 month before study entry
* BCG or local chemotherapy treatment (including VEGF-targeted therapy) in the upper urinary tract within 2 months prior to inclusion
* Systemic chemotherapy treatment (including VEGF-targeted therapy) within 2 months prior to enrollment
* Prohibited medication that could not be adjusted or discontinued prior to study treatment
* Any other medical or psychiatric co-morbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary or liver disease or current heavy smoker that, in the opinion of the study investigator, would make the patient a poor candidate for the study
* Pregnant or breast-feeding women.Women of childbearing potential (WOCBP) must undergo a negative serum pregnancy test prior to study entry.
* Men and women of reproductive potential not willing to observe conventional and effective birth control for the duration of treatment and for 90 days following the last padeliporfin VTP treatment.

Contacts and Locations

Study Contact

Inna Krasnopolskaya, MD

CONTACT

+97253 9656070

i.krasnopolskaya@impactbiotech.com

Principal Investigator

Vitaly Margulis, MD

PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Study Locations (Sites)

University of California - Irvine Medical Center

Irvine, California, 92868

United States

Keck School of Medicine at USC Medical Center

Los Angeles, California, 90033

United States

Emory University Hospital

Atlanta, Georgia, 30322

United States

The Johns Hopkins Hospital, The Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

United States

Albany Medical College

Albany, New York, 12208

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

The Ohio State University (OSU)

Columbus, Ohio, 43210

United States

The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

United States

University of Texas Southwestern

Dallas, Texas, 75390

United States

University of Washington

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Steba Biotech S.A.

Vitaly Margulis, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-22

Study Completion Date2029-01-25

Study Record Updates

Study Start Date2021-03-22

Study Completion Date2029-01-25

Terms related to this study

Keywords Provided by Researchers

UTUC
Low Grade

Additional Relevant MeSH Terms

Transitional Cell Cancer of Renal Pelvis and Ureter