A Trial of a New Type of Photodynamic Therapy (VTP) in the Treatment of Patients With Cancer of the Esophagus Who Have Trouble Swallowing

Esophagogastric Cancer Clinical Trial

Official title:

A Phase I Trial of Vascular-Targeted Photodynamic Therapy in Esophagogastric Cancer Patients With Moderate to Severe Dysphagia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03133650
• Other study ID #: 15-319
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 26, 2017
• Est. completion date: February 23, 2025

Study information

• Verified date: May 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to establish the highest dose of laser light for WST-11 VTP to treat obstruction from esophageal cancer that can be safely given.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: February 23, 2025
• Est. primary completion date: February 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older
• Confirmed tissue diagnosis of esophageal squamous cell cancer, adenocarcinoma or poorly differentiated carcinoma, with pathology reviewed at MSKCC
• Has incurable disease defined as at least one of the following:
• Presence of metastases to other organs (Stage IV), now or previously
• Has locally advanced disease and are not candidates for surgery or more radiation treatment
• Has received the maximal radiation therapy to the primary site, or has been assessed by radiation oncology as not being a candidate for chemoradiation therapy.
• Karnofsky performance status >/= 50%
• No endoluminal stent in place at the time of treatment
• Previous esophageal dilation is permitted, provided the patient has developed recurrent dysphagia since that procedure
• Patients should not have received any systemic therapy (including chemotherapy, biologic therapy or immunotherapy) </= 7 days prior to treatment
• Prior radiation or surgery to the esophagus is permitted for patients with locally recurrent/persistent disease
• 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/ L
• Platelets =75,000/ L
• Hb =8.5 g/dl
• INR =1.5 (except for patients who are on full-dose warfarin)
• Calculated creatinine clearance =50 ml/min (using Cockcroft-Gault method)
• Total serum bilirubin =1.5 mg/dL, or </= 2.5 mg/dL for patients with a known history of Gilbert's syndrome
• 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 of where the partner is sterile
• T4 tumors with involvement of any adjacent structure, including the trachea, aorta or pleura
• Prior history of esophageal perforation
• 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

Related Conditions & MeSH terms

• Deglutition Disorders
• Esophagogastric Cancer
• Moderate to Severe Dysphagia

Intervention

Drug:
• WST 11-mediated VTP therapy
Administration of WST11 in conjunction with endoscopic illumination at 753 nm emitted by a diode laser and administered to the participant by optical fibre catheters (cylindrical light diffusers) and a standard upper GI endoscope.

Locations

Country	Name	City	State
Israel	Weizmann Institute of Science	Re?ovot
United States	Memorial Sloan - Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Steba Biotech S.A., Weizmann Institute of Science

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated laser fluence rate	The maximally tolerated laser light fluence rate (mW/cm) of light exposure for VTP of malignant obstruction due to esophagogastric cancer will be measured by examining 6 fluence rates beginning with a fluence rate of 150 nW/cm, then increasing by 50mW/cm, up to a maximum of 400 mW/cm (150, 200, 250 300, 350, 400).	60 days

External Links

•   Memorial Sloan Kettering Cancer Center