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

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

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Reẖovot, Israel
        • Weizmann Institute of Science
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan - Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vascular-targeted photodynamic therapy (VTP) using WST11
Participants will receive intravenous administration of WST11 at a dose of 4 mg/kg, infused over 10 minutes, during an endoscopy procedure, followed by immediate laser light application.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated laser fluence rate
Time Frame: 60 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hans Gerdes, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2017

Primary Completion (Anticipated)

February 23, 2025

Study Completion (Anticipated)

February 23, 2025

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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