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

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ClinicalTrials.gov Identifier: NCT03133650
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : May 4, 2020
Sponsor:
Collaborators:
Weizmann Institute of Science
Steba Biotech S.A.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Esophagogastric Cancer Moderate to Severe Dysphagia Drug: WST 11-mediated VTP therapy Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Vascular-Targeted Photodynamic Therapy in Esophagogastric Cancer Patients With Moderate to Severe Dysphagia
Actual Study Start Date : April 26, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133650


Contacts
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Contact: Hans Gerdes, MD 212-639-7108 gerdesh@mskcc.org
Contact: David Kelsen, MD 646-888-4179

Locations
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United States, New York
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Hans Gerdes, MD    212-639-7108      
Israel
Weizmann Institute of Science Active, not recruiting
Reẖovot, Israel
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Weizmann Institute of Science
Steba Biotech S.A.
Investigators
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Principal Investigator: Hans Gerdes, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03133650    
Other Study ID Numbers: 15-319
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Vascular-Targeted Photodynamic Therapy (VTP)
15-319
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases