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BRIEF TITLE: Study of WST11 Phototherapy for Upper Tract Urothelial Carcinoma

Phase I Study of WST11 Phototherapy for Upper Tract Urothelial Carcinoma


  • Org Study ID: 18-140
  • Secondary ID:
  • NCT ID: NCT03617003
  • NCT Alias:
  • Sponsor: Memorial Sloan Kettering Cancer Center - Other
  • Source: Memorial Sloan Kettering Cancer Center

Brief 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.

Overal Status Start Date Phase Study Type
Recruiting August 1, 2018 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Maximum tolerated laser fluence rate

Primary Outcome 1 - Time Frame: 2 years

Condition:

  • Upper Tract Urothelial Carcinoma

Eligibility

Criteria:
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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Jonathan Coleman, MD

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Jonathan Coleman, MD

Phone: 646-422-4432

Email: colemanj@mskcc.org

Link: Memorial Sloan Kettering Cancer Center

Location

Facility Status Contact
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Recruiting Jonathan Coleman, MD
646-422-4432