Esophagogastric CancerPhase 1NCT03133650
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 1 study testing WST 11-mediated VTP therapy in people with Esophagogastric Cancer and Moderate to Severe Dysphagia, run by Memorial Sloan Kettering Cancer Center at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagogastric Cancer, Moderate to Severe Dysphagia
- What is being tested?
- WST 11-mediated VTP therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 26 Apr 2017to 23 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Memorial Sloan - Kettering Cancer Center
New York, New York, 10021
Weill Cornell Medical Center (Data Analysis Only)
New York, New York, 10021
About this study
Official title: 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.
- Being tested
- WST 11-mediated VTP therapy
- Keywords
- Vascular-Targeted Photodynamic Therapy (VTP), 15-319
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WST 11-mediated VTP therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Vascular-targeted photodynamic therapy (VTP) using WST11 | Experimental | 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. Receives: Drug: WST 11-mediated VTP therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start26 Apr 2017
- Primary completion23 Feb 2027 (estimated)
- Study completion23 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagogastric CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weizmann Institute of Science, Steba Biotech S.A.
- Responsible party
- Sponsor
- Investigators
- Hans Gerdes, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133650
- Sponsor's protocol ID
- 15-319
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2017
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Vascular-Targeted Photodynamic Therapy in Esophagogastric Cancer Patients With Moderate to Severe Dysphagia
- ClinicalTrials.gov ID
- NCT03133650
- Acronym / sponsor ID
- 15-319
- Keywords
- Vascular-Targeted Photodynamic Therapy (VTP), 15-319
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Weizmann Institute of Science, Steba Biotech S.A.
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 23 Feb 2027 (estimated)
- Study completion
- 23 Feb 2027 (estimated)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vascular-targeted photodynamic therapy (VTP) using WST11 | Experimental | Drug: WST 11-mediated VTP therapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- Karnofsky performance status >/= 50%
- No endoluminal stent in place at the time of treatment
Key exclusion criteria (7 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WST 11-mediated VTP therapyAdministration 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. | Drug | Vascular-targeted photodynamic therapy (VTP) using WST11 |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Gerdes, MD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WST 11-mediated VTP therapy in people with Esophagogastric Cancer and Moderate to Severe Dysphagia, run by Memorial Sloan Kettering Cancer Center at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated laser fluence rate (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.