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Vascular Targeted Therapy

Endoscopy for Urothelial Carcinoma

Phase 1

Waitlist Available

Led By Jonathan Coleman, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate organ function defined at baseline as: ANC ≥1,000/ µL, Platelets ≥75,000/ µL, Hb ≥9 g/dl, INR ≤1.5 (except for patients who are on full-dose warfarin), Calculated creatinine clearance ≥40 ml/min (using Cockcroft-Gault method), Total serum bilirubin ≤1.5 mg/dL, AST/ALT ≤5× upper limit of normal, Able to provide written informed consent

Confirmed tissue diagnosis of urothelial carcinoma involving the ureter and/or renal pelvis with pathology reviewed at MSKCC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether the combination of WST11 and PDT is safe for patients with pancreatic cancer.

Who is the study for?

Adults with urothelial carcinoma in the kidney or ureter, who've had prior endoscopic treatment but still have cancer. They must be fit enough for the procedure (Karnofsky score ≥ 50%), able to pause anticoagulants if needed, and have good organ function. Pregnant women, those not using contraception, and patients with severe other diseases can't join.Check my eligibility

What is being tested?

The trial is testing WST11 mediated vascular targeted phototherapy (VTP) combined with endoscopy on tumors within the urinary system. WST11 is a drug activated by light during endoscopy to destroy tumor cells; this method has been used for other cancers before.See study design

What are the potential side effects?

Potential side effects may include tissue damage at the site of treatment due to light activation of WST11, typical risks associated with endoscopic procedures like infection or bleeding, and any systemic reactions from the drug itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer diagnosis of the ureter or renal pelvis was confirmed by tissue diagnosis.

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My cancer came back after a previous endoscopic treatment.

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I am 18 years old or older.

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I am able to care for myself but cannot do normal activities or work.

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I am not planning to have surgery to remove part of my kidney or ureter.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated laser fluence rate

Side effects data

From 2008 Phase 2 & 3 trial • 58 Patients • NCT00510692

79%

Gastrointestinal

38%

Nervous system disorders

28%

Infections and infestations

24%

General disorders

24%

Musculoskeletal and connective tissue disorders

17%

Respiratory, thoracic and mediastinal disorders

14%

Injury, poisoning and procedural complications

Small bowel obstruction

Neoplasms benign, malignant and unspecified

Breast cancer

Endocrine disorders

Immune system disorders

Investigations

metabolism and nutritional disorders

Renal and urinary disorders

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

2g/Day Eicosapentanoic Acid (EPA)

Trial Design

1Treatment groups

Experimental Treatment

Group I: phototherapy with WST11Experimental Treatment2 Interventions

Patients with urothelial cancer that includes involvement of the upper urinary tract and have failed prior endoscopic treatment, refuse standard treatment, or are ineligible for curative surgical resection of the kidney or ureter will be offered WST11 VTP treatment to be provided at the time of scheduled endoscopic procedure. At the time of endoscopy, patients will be treated with VTP therapy applied to the site of the tumor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Endoscopy

2019

Completed Phase 3

~3320

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,590 Total Patients Enrolled

Jonathan Coleman, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

6 Previous Clinical Trials

538 Total Patients Enrolled

Media Library

WST11 mediated vascular targeted phototherapy (VTP) (Vascular Targeted Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03617003 — Phase 1

Urothelial Carcinoma Research Study Groups: phototherapy with WST11

Urothelial Carcinoma Clinical Trial 2023: WST11 mediated vascular targeted phototherapy (VTP) Highlights & Side Effects. Trial Name: NCT03617003 — Phase 1

WST11 mediated vascular targeted phototherapy (VTP) (Vascular Targeted Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03617003 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety measures are in place for Endoscopy procedures?

"The evidence-based safety assessment of endoscopy, which is currently undergoing its first phase of clinical trials, stands at a 1 on our team's rating scale."

Answered by AI

Are additional participants being accepted for this experiment?

"Evidently, clinicaltrials.gov states that this study is presently not recruiting patients. This research was first shared on August 1st 2018 and the last update to it was made on April 22nd 2022. However, there are currently 2507 other medical trials actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11)

2018. "Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03617003.