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| Name | Class |
|---|---|
| Weizmann Institute of Science | OTHER |
| Steba Biotech S.A. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WST 11-mediated VTP therapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Hans Gerdes, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan - Kettering Cancer Center | New York | New York | 10021 | United States | ||
| Weill Cornell Medical Center (Data Analysis Only) |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| New York |
| New York |
| 10021 |
| United States |
| Weizmann Institute of Science | Rehovot | Israel |