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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03617003
Other study ID # 18-140
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date August 1, 2018
Est. completion date December 2, 2024

Study information

Verified date December 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the safety of a combination of the study drug called WST11 and PDT. Photodynamic therapy (PDT) is a type of ablation therapy (treatment which destroys tumor cells) which has been previously approved for the treatment of patients with other cancers. It works by using a drug that is given through the vein and then is activated in the tumor by light administered during endoscopy, which results in destruction of the cancer cells.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date December 2, 2024
Est. primary completion date December 2, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 or older - Confirmed tissue diagnosis of urothelial carcinoma involving the ureter and/or renal pelvis with pathology reviewed at MSKCC - Residual or recurrent cancer following prior endoscopic treatment - Ineligible, unwilling or refusing to undergo surgical management by resection of involved kidney or ureter. - Karnofsky performance status = 50% - Patients with existing ureteral obstruction and/or existing ureteral stent will be permitted. Demonstration of the site and degree of obstruction must be documented by retrograde pyelography at the time of initial and follow up endoscopic procedures within 60 days. - Patients should not have received any systemic therapy (including chemotherapy, biologic therapy or immunotherapy) =4 weeks prior to treatment - Patients on prophylactic or full-dose anticoagulation are eligible, provided the treating physician believes it is safe to temporarily withhold anticoagulation (see Section 9.2) - 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 Exclusion Criteria: - Pregnant or breast-feeding women. Women of childbearing potential (WOCBP) must undergo a negative pregnancy test (either serum or urine) prior to study entry. Both sexes must use contraception while on study. WOCBP include: - Any woman who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy) or who is not post-menopausal (defined as amenorrheic =12 consecutive months) - Women on hormone replacement therapy with documented serum follicle stimulating hormone level > 35 mIU/ml - Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods to prevent pregnancy or are practicing abstinence or where the partner is sterile - T4 tumors with involvement of the bowel or major blood vessels • Any other medical or psychiatric comorbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary disease that, in the opinion of the study investigator, would make the patient a poor candidate for the study

Study Design


Intervention

Drug:
WST11 mediated vascular targeted phototherapy (VTP)
All patients will receive intravenous administration of WST11 at a dose of 4 mg/kg, infused over 10 minutes while patients are under anesthesia during their endoscopy procedure, followed by immediate laser light application.
Procedure:
Endoscopy
Endoscopy of the bladder

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated laser fluence rate The MTD will be defined as the dose whose toxicity rate does not exceed an acceptable threshold of toxicity 20%.in this study, we shall start at 100mW/cm and will carefully escalate the dose to a maximum of 200 mW/cm. 2 years
See also
  Status Clinical Trial Phase
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Recruiting NCT04948528 - Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma Detection
Recruiting NCT05917158 - A Study of RC48-ADC Combined With JS001 For Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma Phase 2
Recruiting NCT02923557 - Prophylactic Intravesical Chemotherapy to Prevent Bladder Recurrence After Nephroureterectomy for Primary Upper Tract Urothelial Carcinoma Patients Phase 2
Recruiting NCT02969083 - Feasibility of Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma Phase 2
Recruiting NCT03544437 - Feasibility and Safety of Extraperitoneal Laparoscopic Extended Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Upper Tract Urothelial Carcinoma
Recruiting NCT03230201 - Lymph Node Dissection in High-risk UTUC(Upper Tract Urothelial Carcinoma) N/A
Recruiting NCT02740426 - Prophylactic Intravesical Chemotherapy to Prevent Bladder Recurrence After Diagnostic Ureteroscopy for Primary Upper Tract Urothelial Carcinoma Patients Phase 2