Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Male and female patients 18 years or older - Able to understand and provide written willing to sign a consent form 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% - your organs (liver, kidneys, etc.) are working well enough based on blood tests defined at baseline as: - white blood cell count (ANC) at least 1,000/ μl, - platelet count at least 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 Who Should NOT Join This Trial: - 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 • Patients with photosensitive skin diseases or porphyria ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion 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 Exclusion Criteria: * 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 • Patients with photosensitive skin diseases or porphyria * 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.

Treatments Being Tested

DRUG

padeliporfin VTP

During treatment, placement at the target area of an optical light fiber, through the working channel of the ureteroscope. Intravenous administration of padeliporfin at the dose of 3.66 mg/kg infused over 10 minutes. Each target area will be illuminated for 10 minutes.

Locations (18)

University of California - Irvine Medical Center
Irvine, California, United States
Keck School of Medicine at USC Medical Center
Los Angeles, California, United States
Emory University Hospital
Atlanta, Georgia, United States
The Johns Hopkins Hospital, The Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Albany Medical College
Albany, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University (OSU)
Columbus, Ohio, United States
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
CHU de Lille - Hopital Claude Huriez
Lille, France
HCL Hopital Edouard Herriot
Lyon, France
Universitaetsklinikum Tuebingen
Tübingen, Germany
Sheba Medical Center
Ramat Gan, Israel
Hospital Universitario de A Coruña
A Coruña, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain